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

Catalog Number	CATD
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the catd was bent and ovalized starting approximately 30.0 cm from the hub to the distal tip.The catd was flattened from approximately 42.0 cm from the hub to the distal tip.The distal tip of the returned catd was twisted.Conclusions: evaluation of the returned catd revealed a flattened distal region.This damage may have been a result of the catheter tip shifting within its packaging during transit.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 hospital staff noticed that the tip of an indigo system aspiration catheter d (catd) was kinked, flattened, and crushed upon removal from the packaging.The damage to the catd occurred prior to use.Therefore, the catd was not used in the procedure.The procedure was completed using a new catd.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER D
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7520176
• Report Number: 3005168196-2018-01004
• Device Sequence Number: 19178745
• Product Code: DXE
• UDI-Device Identifier: 00814548017624
• UDI-Public: 00814548017624
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/17/2018

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: 02/22/2020
• Device Catalogue Number: CATD
• Device Lot Number: F74552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1