MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F SELECT CATHETER; DQY

Catalog Number	PNS6F125BER
Medical Device Problem Codes	Retraction Problem (1536); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2017
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: 3005168196-2017-01029.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an emergent large vessel occlusion using a neuron max 6f 088 long sheath (neuron max) and a neuron 6f select catheter (6f select).During the procedure, the physician advanced the neuron max into the common carotid artery (cca) and then advanced the 6f select through the neuron max to gain access to the target vessel in the internal carotid artery (ica).Once the neuron max was in place, the physician attempted to retract the 6f select from the neuron max; however, resistance was encountered and the 6f select became stuck in the neuron max and would not retract.Therefore, the physician removed both the neuron max and the 6f select and completed the procedure using a new neuron max.There was no report of an adverse effect to the patient.

• Brand Name: NEURON 6F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6681154
• Report Number: 3005168196-2017-01030
• Device Sequence Number: 11166496
• Product Code: DQY
• UDI-Device Identifier: 00814548012094
• UDI-Public: 00814548012094
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083125
• 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): 06/02/2017

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: 11/16/2019
• Device Catalogue Number: PNS6F125BER
• Device Lot Number: F72877
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 06/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR