MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE64 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE064-A
Medical Device Problem Codes	Fracture (1260); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2016
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system ace 64 reperfusion catheter (ace 64).During the procedure, the physician made a total of ten passes using the ace64 and multiple other devices.During one of the passes, a part of the organized occlusive firm clot on the atherosclerotic plaque at the cavernous internal carotid artery (ica) was aspirated into the ace64.Thereafter, the physician noticed that there were multiple segments within the ace64 that became blocked with clot or plaque.The physician believes that the ace64 may have been kinked at one of the segments and caused the ace64 to unravel and become fractured as it was being removed from the neuron max 6f 088 long sheath (neuron max).The fractured ace64 was safely removed from the patient and the procedure was completed using a new ace 64.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ACE64 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5527703
• Report Number: 3005168196-2016-00368
• Device Sequence Number: 1135873
• Product Code: NRY
• UDI-Device Identifier: 00814548016207
• UDI-Public: 00814548016207
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2016

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: 05/06/2018
• Device Catalogue Number: 5MAXACE064-A
• Device Lot Number: F63855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2016
• Initial Report FDA Received Date: 03/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1