MAUDE Adverse Event Report: 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 09/12/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot# 17945369 presented no issues during the manufacturing process that can be related to the reported complaint.This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During endovascular repair (evar) treatment, the middle part between the 20-gold alloy markers of a 5f 110cm 6 side holes (sh) pigtail (pig) super torque marker bands (mb) diagnostic catheter got broken and fell off the patient¿s aorta.The physician succeeded to remove the catheter using a snare.The mb catheter was handled gentle as per instruction and there were no kinked before the procedure.The device was opened in a sterile field.The device was used with a non-cordis introducer and non-cordis wire.The device will not be returned for evaluation as it was thrown away.

Manufacturer Narrative

During endovascular repair (evar) treatment, the middle part between the 20-gold alloy markers of a 5f pigtail super torque marker band (mb) diagnostic catheter got broken and fell off the patient¿s aorta.The physician succeeded to remove the catheter using a snare.The mb catheter was handled gently as per instruction and there were no kinked conditions before the procedure.The device was opened in a sterile field.The device was used with a non-cordis introducer and non-cordis wire.The device was not returned for analysis as it was discarded.A product history record (phr) review of lot 17945369 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the limited information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device for analysis, the reported customer event ¿catheter (body/shaft) - separated - in-patient¿ could not be confirmed and the exact root cause could not be determined.Procedural/handling factors (evar) or vessel characteristics may have contributed to the reported event.It is noted that pigtail catheters are routinely entrapped during deployment of the aortic bifurcate component of aaa devices and this can cause stretching and narrowing of the catheter when pulled from this entrapment.It is not known whether this is the mechanism in this case.It is also important to ensure hydrophilic wires are properly activated with sterile saline before use to ensure uniform lubricity.According to the ifu, although not intended as a mitigation, ¿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.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.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.Extreme care to avoid stretching or elongation must be exercised during manipulation and withdrawal.Exercise care when removing guidewires from multiple-curve catheters.¿ neither the phr review nor the information available suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10638235
• MDR Text Key: 210174395
• Report Number: 9616099-2020-03958
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 17945369
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2020
• 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: INTRODUCER COOK RCFW 16-OP-38-30-RB; INTRODUCER COOK RCFW18-OP-38-30-RB,; WIRE COOK TSCMG-35-260-LES
• Patient Outcome(s): Life Threatening