MAUDE Adverse Event Report: CORDIS CORPORATION CATH MB 5F PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532598B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.This device has not yet been returned for analysis, so the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, during an evar procedure, a supertorque catheter (cath mb 5f pig 110cm 6sh) separated in the patient and a marker band detached from the catheter.An unknown device was used to capture he separated pieces.Another unknown catheter was used to complete the procedure.There was no patient injury reported.The device was clinically used and will be returned for analysis.

Manufacturer Narrative

As reported, during an endovascular aneurysm repair (evar) procedure, a 5f supertorque marker band catheter (cath mb 5f pig 110cm 6sh) separated in the patient and a marker band detached from the catheter.An unknown device was used to capture he separated pieces.Another unknown catheter was used to complete the procedure.There was no patient injury reported.The device was not returned for analysis.A product history record (phr) review of lot 17722067 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) ¿ separated in patient¿ and ¿marker band (supertorque) ¿ dislodged in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause of the issue could not be determined.Based on the limited information available for review, procedural (evar) and handling factors (such as excessive force) likely contributed to the event reported.As warned in the instructions for use (ifu), which is not intended as a mitigation, ¿failure to observe these instructions may result in damage, breakage or separation of the catheter or the markerbands, which may necessitate additional intervention.Manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.Avoid excessive tension on the device during manipulation.Extreme care to avoid stretching or elongation must be exercised during manipulation and withdrawal.If resistance is felt during manipulation, determine the cause of resistance before proceeding and confirm super torque mb angiographic catheter positioning under high quality fluoroscopic observation.¿ neither the dhr review nor the information available suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

Image review: five jpg images were received for review.Photo 1: an unknown catheter, likely cordis, with six attached gold marker bands that are not equal in distance is pictured.There are three notches noted without marker bands.It appears three of the gold marker bands have moved from their intended position.Photo 2: this appears to be a magnified photo of an unknown catheter, likely cordis.A notch is visualized on the catheter without a marker band on it, and has a red circle drawn around it.A red arrow is drawn pointing to a gold marker band which now sits adjacent to another gold marker band.Photo 3: this photo shows the label and packaging of a 5f pigtail super torque mb 110cm.038¿ angiographic catheter.Lot number is 17722067 and use by date is 2020-08-31.Photo 4: this photo shows a cordis catheter in a plastic bag, with marker bands, and is separated in two pieces.Some marker bands appear to be unequal in distance.Photo 5: this photo is a procedural image of a pelvic region.A catheter with marker bands is visualized.The poor quality of the image makes any detail identification unlikely.Analysis of the images are pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Updated complaint conclusion due to receipt of picture analysis on 30-aug-2019.As reported, during an endovascular aneurysm repair (evar) procedure, a supertorque catheter (cath mb 5f pig 110cm 6sh) separated in the patient and a marker band detached from the catheter.An unknown device was used to capture the separated pieces.Another unknown catheter was used to complete the procedure.There was no patient injury reported.Five jpg images were received for review.Per clinician analysis, photo 1 is an unknown catheter, likely cordis, with six attached gold marker bands that are not equal in distance.There are three notches noted without marker bands.It appears three of the gold marker bands have moved from their intended position.Photo 2 appears to be a magnified image of an unknown catheter, likely cordis.A notch is visualized on the catheter without a marker band on it, and has a red circle drawn around it.A red arrow is drawn pointing to a gold marker band which now sits adjacent to another gold marker band.Photo 3 shows the label and packaging of a 5f pigtail super torque mb 110cm.038¿ angiographic catheter.The lot number is 17722067 and use by date is 2020-08-31.Photo 4 shows a cordis catheter in a plastic bag, with marker bands, and is separated in two pieces.Some marker bands appear to be unequal in distance.Photo 5 is a procedural image of a pelvic region.A catheter with marker bands is visualized.The poor quality of the image makes any detail identification unlikely.The actual product was not returned for analysis.However, a file with five pictures of a cath mb 5f pig 110 cm 6sh diagnostic catheter were received for analysis.Per visual analysis, one picture shows a label of a 5f pig 110 cm.038" with part number 532598b and lot number 17722067.Other pictures show a separated catheter and maker bands that were observed to be moved from their intended position on the catheter.A product history record (phr) review of lot 17722067 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer as ¿marker band (supertorque) - dislodged - in-patient¿ was not confirmed since per picture analysis, marker bands were observed only moved from their intended position and not dislodged from the catheter.The event reported by the customer as ¿catheter (body/shaft) - separated - in-patient¿ was confirmed by picture analysis since the unit was observed to be separated.However, the exact cause of the moved marker bands and separated catheter cannot be conclusively determined based solely on the picture visual analysis and information provided.Procedural (evar) and handling factors likely contributed to the event reported.As warned in the instructions for use (ifu), which is not intended as a mitigation of risk, ¿failure to observe these instructions may result in damage, breakage or separation of the catheter or the markerbands, which may necessitate additional intervention.Manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.Avoid excessive tension on the device during manipulation.Extreme care to avoid stretching or elongation must be exercised during manipulation and withdrawal.If resistance is felt during manipulation, determine the cause of resistance before proceeding and confirm super torque mb angiographic catheter positioning under high quality fluoroscopic observation.¿ neither the phr review nor the picture analysis suggest that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

Manufacturer Narrative

The device was returned along with 4 additional devices were received and section d10 was updated accordingly.The completed engineering report will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, during an endovascular aneurysm repair (evar) procedure, a super torque catheter (cath mb 5f pig 110cm 6sh) separated in the patient and a marker band detached from the catheter.An unknown device was used to capture the separated pieces.Another unknown catheter was used to complete the procedure.There was no patient injury reported.Five jpg images were received for review.Per clinician analysis, photo 1 is an unknown catheter, likely cordis, with six attached gold marker bands that are not equal in distance.There are three notches noted without marker bands.It appears three of the gold marker bands have moved from their intended position.Photo 2 appears to be a magnified image of an unknown catheter, likely cordis.A notch is visualized on the catheter without a marker band on it, and has a red circle drawn around it.A red arrow is drawn pointing to a gold marker band which now sits adjacent to another gold marker band.Photo 3 shows the label and packaging of a 5f pigtail super torque mb 110cm.038¿ angiographic catheter.The lot number is 17722067 and use by date is 2020-08-31.Photo 4 shows a cordis catheter in a plastic bag, with marker bands, and is separated in two pieces.Some marker bands appear to be unequal in distance.Photo 5 is a procedural image of a pelvic region.A catheter with marker bands is visualized.The poor quality of the image makes any detail identification unlikely.One non-sterile unit of cath mb 5f pig 110cm 6sh diagnostic catheter was received for analysis.Per visual analysis, the unit was observed separated on the body, and 5 out of 20 marker bands were found moved/out of position at the proximal section of the unit.The marker band marks on the unit¿s surface in the proximal section did not present evidence of damage (scratches, peelings, abrasions, etc.).The catheter showed 5 marker bands (mb 1,2,7,8, and 9) moved from their original place.Marker bands 3 through 6 and 10 through 20 remained in their original positions (the position of the marker bands is numerated from the hub to the distal end).No other anomalies were observed on the unit.The outer diameter (od) and inner diameter (id) of the distal section was measured close to the areas where the marker bands were out of position and results were found within specification.A guidewire was not inserted through the separated catheter due to its received condition.Per microscopic analysis of separated catheter, sem results showed that the observed separated sections of the catheter show irregular edges, elongations, and material transfer at the area of the separation, which indicates that both segments were correctly fused.Also, the braid wires show plastic deformations and diameter reduction.Elongations are a common characteristic of pieces which were stretched/pulled until separation.Also, the braid wires presented plastic deformations and diameter reduction, commonly associated with ductile separations cause by material tensile overload.The available evidence may suggest an application of stress that exceeded the material yield strength or a tensile overload that led to the separation.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 17722067 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer as ¿catheter (body/shaft) - separated - in-patient¿ was confirmed since a section on the catheter body was observed to be separated.Per sem microscopic analysis, elongations and material transfer were observed on the catheter body.Also, the catheter¿s braid wires show plastic deformations and diameter reduction.Elongations observed on body material is a common characteristic of pieces that were stretched/pulled until separation occurred.Plastic deformations and diameter reduction are commonly associated with ductile separations caused by material tensile overload.The available evidence may suggest an application of stress that exceeded the material yield strength or a tensile overload that led to the separation.The event reported by the customer as ¿marker band (supertorque)- dislodged - in-patient¿ was confirmed due to catheter marker bands were observed moved/out of their intended position on the catheter, as received.However, the exact cause of this condition could not be conclusively determined during the analysis since the device did not present any obvious indication of manufacturing defect or anomaly that could contribute to the event as reported.Results showed that the sections with evidence of marker bands displacement presented no anomalies or evidence as to determine what caused the marker bands movement; however, it can be assured that the marker bands were placed on the correct position at a certain time owing to the outer diameter reduction of the body.Procedural (evar) and handling factors likely contributed to the event reported.As warned in the instructions for use (ifu), which is not intended as a mitigation of risk, ¿failure to observe these instructions may result in damage, breakage or separation of the catheter or the markerbands, which may necessitate additional intervention.Manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter.In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.Avoid excessive tension on the device during manipulation.Extreme care to avoid stretching or elongation must be exercised during manipulation and withdrawal.If resistance is felt during manipulation, determine the cause of resistance before proceeding and confirm super torque mb angiographic catheter positioning under high quality fluoroscopic observation.¿ neither the phr review nor the product analysis suggest that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8686324
• MDR Text Key: 147570289
• Report Number: 9616099-2019-03010
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032012031
• UDI-Public: 20705032012031
• Combination Product (y/n): N
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 17722067
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention