MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT RX KIT; DXE

Catalog Number	CATRXKIT160
Medical Device Problem Codes	Bent (1059); Aspiration Issue (2883)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the indigo system cat rx (catrx) was kinked approximately 135.0 cm from the hub.Conclusions: evaluation of the returned catrx revealed that it was kinked.This damage may have occurred due to forceful handling of the catrx during advancement or positioning within patient anatomy.The observed kink likely contributed to the aspiration stopping during the procedure.The non-penumbra sheath and wire mentioned in the complaint were not returned for evaluation.Penumbra catheters are 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the ulnar artery using an indigo system cat rx kit (kit).During the procedure, the physician advanced the indigo system cat rx aspiration catheter (catrx) into the target vessel through a non-penumbra sheath and over a non-penumbra wire.After aspiration was performed for a total of three minutes in the ulnar artery, the catrx was removed.The physician did not mention resistance during the procedure; however, aspiration stopped.While removing the catrx from the sheath, the physician noticed that it was bent.Therefore, the catrx was set aside and the procedure was successfully completed using an indigo system cat3 aspiration catheter (cat3) through the same sheath and over the same wire.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT RX KIT
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6785429
• Report Number: 3005168196-2017-01377
• Device Sequence Number: 1540985
• Product Code: DXE
• UDI-Device Identifier: 00814548017587
• UDI-Public: 00814548017587
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K163618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2017

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
• Operator of Device: Physician
• Device Expiration Date: 03/15/2020
• Device Catalogue Number: CATRXKIT160
• Device Lot Number: C01117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR