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

Catalog Number	PNS6F125BER
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron select catheter 6f (6f select) was ovalized from 2.0-7.0, 18.0-25.0, 95.0-98.0, and 102.0-105.0 cm from the hub.Conclusions: evaluation of the returned 6f select revealed multiple ovalized regions along the length of the catheter.This damage are likely a result of improper handling during preparation and may have been due to forceful gripping of the catheter during preparation.During functional analysis, a 0.035¿ mandrel, matching the size of the reported guidewire, was unable to advance past the proximal ovalizations confirming the reported complaint.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.
Event or Problem Description
While preparing a neuron select catheter 6f (6f select) for a thrombectomy procedure, the physician flushed the 6f select and attempted to load a glidewire through it; however, the glidewire would not advance.Therefore, the 6f select was set aside and the procedure was completed using another 6f select and the same wire.

• Brand Name: NEURON SELECT CATHETER 6F
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7153014
• Report Number: 3005168196-2017-02311
• Device Sequence Number: 13713993
• Product Code: DQY
• UDI-Device Identifier: 00814548012094
• UDI-Public: 00814548012094
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K070970
• 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): 11/30/2017

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: No Information
• Device Expiration Date: 08/15/2020
• Device Catalogue Number: PNS6F125BER
• Device Lot Number: F78710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1