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

Catalog Number	5MAXACE064
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2016-00887.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using penumbra system 3max reperfusion catheter (3max) and penumbra system ace 64 reperfusion catheter (ace 64).During the procedure, while being used through the ace 64 to remove thrombus, the 3max was pulled back and it became stuck inside the ace 64, and the 3max tip separated inside the ace 64; therefore, the physician removed the ace 64 with the 3max inside and completed the procedure using a new 3max with a new ace 64.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the penumbra system ace 64 reperfusion catheter (ace 64) was bent in multiple locations along the distal shaft, and ovalized on the distal tip.The non-penumbra guidewire was kinked in multiple locations along its length.Conclusion: evaluation of the returned penumbra system 3max reperfusion catheter (3max) revealed it was fractured and stretched.This type of damage typically occurs due to forceful retraction of the 3max against resistance.It is possible for the distal segment of the 3max to become restrained against patient anatomy or other devices used in the procedure that may have prolapsed in the patient anatomy.If the distal segment of 3max is pinned or otherwise restrained, and then forcefully withdrawn against the resistance, the catheter shaft may become stretched and fractured.Further evaluation revealed the 3max was kinked and ovalized on the distal tip.This damage likely occurred due to forceful manipulation of the 3max during positioning within anatomy.Evaluation of the returned ace 64 revealed it was bent in multiple locations along the distal shaft and ovalized on the distal tip.This damage typically occurs due to forceful manipulation of the ace 64 during use.The damage observed on the ace 64 may have contributed to the 3max becoming stuck during retraction.Penumbra catheters are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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: 5746472
• Report Number: 3005168196-2016-00888
• Device Sequence Number: 18837007
• Product Code: NRY
• UDI-Device Identifier: 00814548013961
• UDI-Public: 00814548013961
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K152541
• 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,Followup
• Report Date (Section B): 05/27/2016

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: 11/22/2018
• Device Catalogue Number: 5MAXACE064
• Device Lot Number: F66625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2016
• Supplement Report FDA Received Date: 08/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR