MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 HI-FLOW KIT; NRY

Catalog Number	5MAXACE068KIT-A
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 using a penumbra system ace 68 reperfusion catheter kit.During the procedure, the penumbra system ace 68 reperfusion catheter (ace 68) was locked into the rotating hemostasis valve (rhv) and moved in a non linear manor to the system which resulted in a kink at the proximal shaft.Therefore, the ace 68 was removed and the procedure was completed using a new ace 68.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5978021
• Report Number: 3005168196-2016-01381
• Device Sequence Number: 570258
• Product Code: NRY
• UDI-Device Identifier: 00814548016597
• UDI-Public: 00814548016597
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142458
• 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): 08/30/2016

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: Health Professional
• Device Expiration Date: 05/25/2019
• Device Catalogue Number: 5MAXACE068KIT-A
• Device Lot Number: F69496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2016
• Initial Report FDA Received Date: 09/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 85