MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 6 ASPIRATION CATHETER; DXE

Catalog Number CAT6

Device Problems Difficult to Insert (1316); Material Deformation (2976); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the cat6 was ovalized approximately 125.0, 131.0, and 133.0 thru 135.0 cm from the hub.Conclusions: evaluation of the first evaluated cat6 revealed that the device was ovalized.If the peel-able introducer sheath supplied by penumbra is not used during insertion and the catheter shaft is forcefully gripped or pinched, damage such as this may occur.The ovalization in the distal shaft of the cat6 likely contributed to the difficulty during insertion.Evaluation of the second evaluated cat6 revealed that the device was fractured.If the device is forcefully retracted against resistance through a damaged device, damage such as this may occur.Further evaluation of the returned device revealed that the cat6 was ovalized and kinked.This damage was likely incidental and may have occurred while packaging the device for return.Evaluation of the non-penumbra sheath revealed that the sheath was kinked and the distal fractured segment of the cat6 was inside the sheath lumen.The non-penumbra microcatheter and sep6 referred to in the complaint were not returned to penumbra for evaluation.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2018-00829.

Event Description

The patient was undergoing a thrombectomy procedure in the popliteal artery to anterior tibial artery using an indigo system cat6 aspiration catheter (cat6).During the procedure, the physician experienced difficulty inserting a cat6 into a non-penumbra sheath, despite using a guidewire.Consequently, the physician pinched down on the cat6 while attempting to advance it and the tip of the cat6 became crunched and deformed, and therefore the cat6 and the sheath were removed.The physician then inserted a new non-penumbra sheath and made multiple passes using a new cat6 with an indigo system separator 6 (sep6).The thrombus was successfully cleared; however, while attempting to retract and remove the cat6, the physician experienced resistance and the tip of the cat6 broke off within the sheath.The physician, therefore, removed the sep6 and inserted a guidewire and was able to remove the sheath with the tip of the cat6 inside.The procedure was then completed using a new sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT 6 ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7451495
• MDR Text Key: 106256874
• Report Number: 3005168196-2018-00828
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2018

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: Physician
• Device Expiration Date: 12/12/2020
• Device Catalogue Number: CAT6
• Device Lot Number: F80990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2017
• 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
• Patient Age: 57 YR