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

Catalog Number	5MAXACE068KIT
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2016
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system ace 68 reperfusion catheter (ace 68).During the procedure, the tip of the ace 68 became collapsed after continued use.Therefore, the ace 68 was removed and the procedure was completed using non-penumbra devices.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the penumbra system ace 68 reperfusion catheter (ace 68) was bent approximately 110.0 cm from the hub.The ace 68 was kinked repeatedly from 118.0 cm from the hub to the distal tip.The ace 68 was stretched approximately 131.0 cm from the hub.Conclusions: evaluation of the device revealed the distal tip of the ace 68 was repeatedly kinked, and the distal region was bent and stretched.These damages are likely a result of the repeated attempts to advance and retract the ace 68 against resistance.The non-penumbra devices mentioned in the complaint were not returned for evaluation.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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: 6276074
• Report Number: 3005168196-2017-00115
• Device Sequence Number: 13664025
• Product Code: NRY
• UDI-Device Identifier: 00814548016597
• UDI-Public: 00814548016597
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K161640
• 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,Followup
• Report Date (Section B): 12/28/2016

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: 06/08/2019
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F71727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2017
• Supplement Report FDA Received Date: 03/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR