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

Catalog Number	5MAXACE064
Medical Device Problem Codes	Structural Problem (2506); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2017
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 device is not available for return.
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 radiopaque marker on the distal tip of the ace 64 was not fully visible and was partially seen under fluoroscopy.Therefore, the ace 64 was removed and the procedure was completed using a new ace 64.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device in complaint was not expected to be returned but was received by the manufacturer on 03/15/2017 for evaluation.Results: the ace 64 was kinked approximately 113.0 and 117.0 cm from the hub.The markerband was present on the distal end of the ace 64 and had no damage or abnormalities.Conclusions: evaluation of the returned device revealed that the markerband was present on the distal end of the ace 64 and had no damage or abnormalities.The root cause of only partial visibility of the markerband during the procedure could not be determined.Further evaluation revealed the ace 64 was kinked.This damage was likely incidental and may have occurred due to forceful handling during preparation or use.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.

• 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: 6337595
• Report Number: 3005168196-2017-00174
• Device Sequence Number: 10984380
• Product Code: NRY
• UDI-Device Identifier: 00814548013961
• UDI-Public: 00814548013961
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2017

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: 02/21/2019
• Device Catalogue Number: 5MAXACE064
• Device Lot Number: F68014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 04/26/2017
• 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