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

Catalog Number	5MAXACE064
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system ace 64 reperfusion catheter (ace64) was kinked at its distal tip.Conclusions: evaluation of the returned psr3d revealed the stent portion had separated from its delivery wire due to both of the stent struts fracturing at the attachment tip.Based on the uniform bends on the fractured struts of the stent, it is likely this damage is a result of being retracted against resistance around a sharp bend in the patient anatomy.Further evaluation revealed a kink on the ace64¿s distal tip.This damage is likely a result of the stent being retracted and lodged into the ace64¿s distal tip.This kink likely contributed to the resistance experienced while advancing and retracting a mandrel through the ace64 during functional testing.Penumbra catheters and stents 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.This report is associated with mfr report number: 3005168196-2017-02161.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d), a neuron max 6f 088 long sheath (neuron max), a penumbra system ace 64 reperfusion catheter (ace64) and a non-penumbra catheter.During the procedure, after advancing the psr3d through the ace64 and capturing the clot, the physician attempted to retract the psr3d into the ace64.It was noted that the physician experienced resistance.While attempting to retract the ace64 and psr3d from the patient, the physician noticed that the ace64 was stretching.Therefore, the physician loosened the rotating hemostasis valve (rhv) and removed the ace64 containing the psr3d from the patient.Upon removal, the physician noticed that the stent component of the psr3d was separated from the pusher wire and stuck inside the ace64, but the clot was still attached to the psr3d.The final angiography revealed that the thrombectomy procedure was successfully performed and the procedure was completed at this point.In addition, there was no alleged deficiency with the neuron max.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: 7098041
• Report Number: 3005168196-2017-02162
• Device Sequence Number: 782554
• Product Code: NRY
• UDI-Device Identifier: 00814548013961
• UDI-Public: 00814548013961
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• 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
• Report Date (Section B): 11/09/2017

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: 03/08/2020
• Device Catalogue Number: 5MAXACE064
• Device Lot Number: F74871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1