MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 5F SELECT CATHETER; DQY

Catalog Number	PNS5F130BER
Medical Device Problem Codes	Break (1069); Material Separation (1562); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
While preparing a neuron select catheter 5f (5f select) to be used for a thrombectomy procedure, the physician noticed the 5f select tip sheared off while being advanced through a non-penumbra guiding catheter outside of the patient's body.The tip of the 5f select sheared off prior to use and therefore was not used for the procedure.The procedure was completed using another manufacturer's catheter.
Additional Manufacturer Narrative
Results: the neuron select catheter 5f (5f select) fractured approximately 123.0 cm from the hub.There was no gross yielding distal or proximal to the fracture.Conclusions: evaluation of the returned device revealed it was fractured at the proximal and distal shaft junction.This type of damage typically occurs due to improper handling during use.If the select is forcefully handled at an angle during insertion into a parent catheter, damage such as this may occur.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.

• Brand Name: NEURON 5F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6001141
• Report Number: 3005168196-2016-01410
• Device Sequence Number: 16311649
• Product Code: DQY
• UDI-Device Identifier: 00814548010212
• UDI-Public: 00814548010212
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 09/07/2016

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: 06/20/2019
• Device Catalogue Number: PNS5F130BER
• Device Lot Number: F70201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2016
• Supplement Report FDA Received Date: 11/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1