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

Catalog Number PNS6F125BER

Device Problem Failure to Advance (2524)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2017

Event Type  malfunction  

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 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
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7153014
• MDR Text Key: 96128471
• Report Number: 3005168196-2017-02311
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548012094
• UDI-Public: 00814548012094
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1