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 Foreign Body In Patient (2687)

Event Date 11/16/2022

Event Type  Injury  

Event Description

As reported, a 5f 110cm 6sh pigtail super torque angiographic catheter ruptured intravascularly when it was pulled out during an angiographic procedure.As a result, only the lower part of the catheter was withdrawn initially, and the tip remained in the patient's vessel, until it was subsequently retrieved via a snare.There were no reports of patient injury.The incident happened while using a non-cordis prosthesis.There were problems withdrawing the catheter from the patient and the catheter ruptured.2 gold markers had remained in the patient: one in the prosthesis and the other slipped in the leg.The patient is doing well so far.The access vessel site was the femoral artery.The device was stored and prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The user of the device was trained.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18130564 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: d8, d9, g3, g6, h1, h2, h3, and h10.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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, a 5f 110cm 6sh pigtail super torque angiographic catheter ruptured intravascularly when it was pulled out during an angiographic procedure.As a result, only the lower part of the catheter was withdrawn initially, and the tip remained in the patient's vessel, until it was subsequently retrieved via a snare.There were no reports of patient injury.The incident happened while using a non-cordis prosthesis.There were problems withdrawing the catheter from the patient and the catheter ruptured.2 gold markers had remained in the patient.One in the prosthesis and the other slipped in the leg.The patient is doing well so far.The access vessel site was the femoral artery.The device was stored and prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The user of the device was trained.The device was returned for analysis.A non-sterile unit of product ¿cath mb 5f pig 110cm 6sh¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked to and found to be separated in two pieces, both segments were returned.The separation is located at 20 cm from the distal tip.The unit also presents markers band out of position.The marker bands 16, 17 and 18 present an offset/out of position condition.Marker bands 19 and 20 are dislodged and were not returned for analysis.A severe twisted condition was observed on the body/shaft approximately at 5.5 cm from the separated edge.Per dimensional analysis.The inner and outer diameter (id, od) of the body shaft was measured near the areas where the marker bands are out of position.The dimensional analysis results were found out of specification.The results indicate that the unit is elongated with the diameter reduced below the lower spec.A dimensional analysis was performed near the separated edges.Measurements were taken at one cm from the separated edges of the two pieces and found to be below the lower spec.This result indicates that the unit is elongated at this area.Per functional analysis.One 0.038¿ lab sample guidewire was inserted inside the catheter via the distal tip at the distal segment.The guide wire could not be passed through all the segment, this condition was caused due to the marker bands out of position reduced id.The marker bands were inspected with a vision system to obtain a magnified image.No anomalies or damages were observed.Per sem analysis.Sem results showed that the complaint catheter unit body presented evidence of material elongation and striation patterns across the separation borders of the body separation, this type of damage is commonly caused during the exposure of an excessive tensile force that may cause these types of mechanical damages.It is very likely that excessive force applied in the affected area could probably led to the damaged condition found on the received device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 18130564 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 and marker band dislodged¿ was confirmed.With the limited information provided it is not possible to determine an exact cause for the event.Catheter separation failures are commonly associated with elongations caused by material tensile overload.Therefore, it is assumed that the catheter was induced to a tensile force that exceeded its material yield strength prior to the separation.Procedural factors such as proper flushing of the device, vessel characteristics or entrapment of the catheter between other endovascular devices and the vessel wall may have contributed to this issue.Although not intended as a mitigation of risk, information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), ¿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 entrapment of the catheter between other endovascular devices and the vessel wall.¿ based on the information available, the device analysis and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective 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
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16040706
• MDR Text Key: 306068417
• Report Number: 9616099-2022-06177
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 18130564
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDTRONIC ENDURANT 2 STENT CRAFT SYSTEM
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 48 YR