MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE064
Medical Device Problem Codes	Kinked (1339); Aspiration Issue (2883); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2016
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 using the penumbra system ace 64 reperfusion catheter (ace 64).During the procedure, after successfully using the ace 64 to aspirate thrombus, the physician noticed the aspiration was no longer effective; therefore the ace 64 was removed.Upon removing the ace 64 from the patient, the physician noticed it had become kinked, ovalized and was collapsing.Therefore, the procedure was completed using a new ace 64 and the same non-penumbra sheath.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6196212
• Report Number: 3005168196-2016-01856
• Device Sequence Number: 758976
• Product Code: NRY
• UDI-Device Identifier: 00814548013961
• UDI-Public: 00814548013961
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2016

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: Physician
• Device Expiration Date: 09/02/2018
• Device Catalogue Number: 5MAXACE064
• Device Lot Number: F65573
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2016
• Initial Report FDA Received Date: 12/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR