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

Catalog Number	PNS5F130SIM
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron 5f select catheter (5f select) was kinked approximately 115.0 cm from the hub and fractured approximately 121.0 cm from the hub.Conclusions: evaluation of the returned device revealed it was fractured in the distal shaft.This type of damage typically occurs due to improper handling during use.If the 5f select is forcefully handled during insertion into an rhv, damage such as this may occur.The rhv mentioned in the complaint was not returned for evaluation.5f select devices are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a medical procedure using a neuron 5f select catheter (5f select).During the procedure, while the 5f select was being loaded into the rotating hemostasis valve (rhv) for the second time, the tip of the 5f select snapped off.Therefore, the 5f select was removed and the procedure was completed using a new 5f select and the same rhv.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Additional narrative and/or corrected data on the initial mfr.Report incorrectly stated the following: "the manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns." the sentence above should have read as follows: "the product lot number was not provided, therefore, the manufacturing records could not be reviewed.".

• Brand Name: NEURON 5F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5799875
• Report Number: 3005168196-2016-00999
• Device Sequence Number: 16144529
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 00814548010236
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 06/16/2016

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 Catalogue Number: PNS5F130SIM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2016
• Supplement Report FDA Received Date: 07/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR