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

Model Number 532598B

Device Problems Structural Problem (2506); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

Event Type  malfunction  

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 is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 5f 110cm 6 side holes (sh) super torque mb angiographic catheter had snapped.Upon inspection after the snapped, the 20 gold markers were still present, the catheter was separated just before the first gold marker (26cms) from the tip of the catheter.It has been observed that the first gold marker has moved from its original location and is now found next to the second gold marker.There was no reported patient injury.The incident occurred while the patient was having an endovascular treatment of abdominal aortic aneurysms (evar) with embolization of the internal iliac artery.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the 5f 110cm 6 side holes (sh) super torque mb angiographic catheter had snapped.Upon inspection after the snapped, the 20 gold markers were still present, the catheter was separated just before the first gold marker (26cms) from the tip of the catheter.It has been observed that the first gold marker has moved from its original location and is now found next to the second gold marker.Therefore, the procedure was completed using a non-cordis device.There was no reported patient injury.The incident occurred while the patient was having an endovascular treatment of abdominal aortic aneurysms (evar) with embolization of the internal iliac artery.The device was stored and handled as per the instruction for use (ifu).There were no damages noted to the packaging of the device prior to use.The device was prepped according to the ifu.The device did not kink or bend at any time prior to the procedure.Currently, the patient is hemodynamically stable.The separated catheter was retrieved during the removal of the femoral sheath.All the marker bands were accounted for after removal of the device.Other procedural details/patient information were requested but were unknown.A non-sterile unit of a super torque mb diagnostic catheter (cath mb 5f pig 110cm 6sh) was received for analysis coiled inside of a clear plastic bag.A separated condition was observed on the returned unit located at 25 cm from the distal tip, both separated segments were returned for analysis.Also, it was observed that marker band number 20 was moved from their original position and it was found piled up together with the number 19.All marker bands are present on the catheter body, none were missing.(the position of the marker bands is numerated from the distal end to the hub).No other damages or anomalies were found.The dimensions of the inner diameter (id) and outer diameter (od) were measured.Measurements were taken on the area located between the assigned position of the markers bands 19 and 20.The dimensional analysis results were found out of specification due to the elongated condition observed on the returned part.The unit was observed under a microscope and the marker band marks on unit¿s surface did not present evidence of damage (scratches, peelings, abrasions, etc.).No other issues were noted during microscopic analysis of the marker bands area.Sem results showed that the received device presented the distal tip of the inner body separated.The observed separated condition shows irregular edges on the body distal tip separation.Also, sem results showed that the separated sections of samples a and b of the body areas presented evidence of elongations.Elongations is a common characteristic of pieces which were stretched/pulled until separation.The available evidence may suggest an application of stress that exceeded the material yield strength or a tensile overload that led the material separation.No other anomalies were found during sem analysis.A product history record (phr) review of lot 17886822 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿catheter (body/shaft) - separated in patient¿ was confirmed, a separated condition was observed on the body of the returned catheter.The complaint reported by the customer as ¿marker band (super torque) - offset/out of position in patient¿ was confirmed.A marker band - offset/out of position condition was observed at the returned device.Exact cause of these anomalies could not be conclusively determined during the analysis.Procedural/handling factors (evar) or vessel characteristics may have contributed to the reported event.Per the elongations found on catheter body, it was determined that this may have been the cause of marker band migration and catheter separation.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿prior to using the device, inspect for bends, kinks or other damage.Failure to observe these instructions may result in damage, breakage or separation of the catheter or the markerbands, which may necessitate additional intervention.Avoid entrapment of the catheter between other endovascular devices and the vessel wall.Avoid excessive friction on the catheter; avoid simultaneous introduction of the catheter and aortic graft devices through the same sheath.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 suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.

Event Description

As reported, the 5f 110cm 6 side holes (sh) super torque mb angiographic catheter had snapped.Upon inspection after the snapped, the 20 gold markers were still present, the catheter was separated just before the first gold marker (26cms) from the tip of the catheter.It has been observed that the first gold marker has moved from its original location and is now found next to the second gold marker.Therefore, the procedure was completed using a non-cordis device.There was no reported patient injury.The incident occurred while the patient was having an endovascular treatment of abdominal aortic aneurysms (evar) with embolization of the internal iliac artery.The device was stored and handled as per the instruction for use (ifu).There were no damages noted to the packaging of the device prior to use.The device was prepped according to the ifu.The device did not kink nor bent at any time prior to the procedure.Currently, the patient is hemodynamically stable.The separated catheter was retrieved during the removal of the femoral sheath.All the marker bands were accounted for after removal of the device.Other procedural details/patient information were requested but were unknown.The device will be returned for evaluation.

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

• 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: 9808184
• MDR Text Key: 197611517
• Report Number: 9616099-2020-03555
• 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
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 17886822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 03/08/2020; 04/03/2020
• Supplement Dates FDA Received: 04/02/2020; 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1