MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT5 ASPIRATION CATHETER; DXE

Catalog Number	CAT5
Medical Device Problem Codes	Physical Resistance (2578); Aspiration Issue (2883); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the peroneal artery using an indigo system cat5 aspiration catheter (cat5).During the procedure, the physician made two successful passes using the cat5 through a non-penumbra 6f sheath, then had difficulty crossing a section and noticed that nothing was being aspirated.It was reported that the physician encountered resistance half way down the mid-anterior tibial artery.The physician then retracted the cat5 to flush and noticed that it was severely kinked.Therefore, the procedure was completed using a new cat5 and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Pma/510(k) # was incorrectly reported on the initial mfr report and is being corrected on this follow-up #1 mfr report.

• Brand Name: INDIGO SYSTEM CAT5 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6786891
• Report Number: 3005168196-2017-01390
• Device Sequence Number: 1570338
• Product Code: DXE
• UDI-Device Identifier: 00814548016092
• UDI-Public: 00814548016092
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2017

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: 06/16/2019
• Device Catalogue Number: CAT5
• Device Lot Number: F70145
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 95