MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 ASPIRATION CATHETER; DXE

Catalog Number	CAT8TORQ85
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the cat8 was kinked approximately 77.0 thru 86.5 cm from the hub.Conclusions: evaluation of the returned device revealed that the distal shaft of the cat8 was kinked.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance during insertion, damage such as this may occur.The root cause of the initial resistance could not be determined.A mandrel was attempted to be advance through the cat8.While advancing the mandrel through the cat8; resistance was encountered as the mandrel met the kinks in the distal shaft of the cat8 and the mandrel could not be advanced any further.The non-penumbra sheath referred to in the complaint was not returned 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.
Event or Problem Description
During preparation for a thrombectomy procedure, the physician experienced resistance while attempting to insert an indigo system aspiration catheter 8 (cat8) into a non-penumbra sheath on the back table and consequently, the distal tip of the cat8 became kinked.It was reported that the cat8 never entered the sheath.The cat8 became damaged prior to use and therefore, was not used in the procedure.The procedure was completed using the same sheath and a new cat8.

• Brand Name: INDIGO SYSTEM CAT 8 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7297854
• Report Number: 3005168196-2018-00412
• Device Sequence Number: 19051809
• Product Code: DXE
• UDI-Device Identifier: 00814548016252
• UDI-Public: 00814548016252
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• 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): 01/31/2018

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
• Operator of Device: Physician
• Device Expiration Date: 07/19/2020
• Device Catalogue Number: CAT8TORQ85
• Device Lot Number: F78273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1