MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER; NRY

Catalog Number	PSC054
Medical Device Problem Codes	Break (1069); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2017
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.This report is associated with mfr report number: 3005168196-2017-00599: the hospital disposed of the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using a neuron max 6f 088 (neuron max) and a penumbra system 5max reperfusion catheter (5max).It was reported that the patient had an extremely tortuous aortic arch.During the procedure, the physician experienced resistance while making the turn from the aortic arch into the left common carotid artery and noticed that the neuron max became kinked mid/distal shaft.However, the physician was able to resolve enough of the kink to pass a 5max, another manufacturer¿s catheter and microcatheter, and a stent retriever device through the neuron max.While removing the 5max from the neuron max, the physician experienced slight resistance and it was assumed the neuron max must have kinked again.Upon completely removing the 5max from the neuron max, the physician noticed that the tip of the 5max had sheared off and was still inside the neuron max.The physician then re-wired the neuron max and successfully removed the fragmented 5max tip without issue.The procedure was successfully completed using the same neuron max and the other manufacturer¿s catheters.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6491551
• Report Number: 3005168196-2017-00598
• Device Sequence Number: 1642471
• Product Code: NRY
• UDI-Device Identifier: 00814548012742
• UDI-Public: 00814548012742
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/20/2017

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: 06/09/2019
• Device Catalogue Number: PSC054
• Device Lot Number: F70045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2017
• Initial Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR