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

Catalog Number	PNS6F125SIM
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron 6f select catheter (6f select) hub was cracked.The 6f select was kinked approximately 0.2 cm from the hub.Conclusions: evaluation of the returned device revealed that the hub was cracked.This type of damage typically occurs due to over-tightening of an accessory on the hub.Further evaluation of the 6f select revealed that the catheter was kinked in the proximal shaft.This damage likely occurred due to improper manipulation during preparation of the device.If the catheter is forcefully gripped during attempts to attach the rhv, this type of damage may occur.Penumbra catheters 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
During preparation for a medical procedure, while attaching the rotating hemostasis valve (rhv) to a neuron 6f select catheter (6f select), the hospital staff noticed that the 6f select hub was broken.The broken hub was noticed prior to use while outside of the patient; therefore, the 6f select was not used for the procedure.The procedure was completed using a new 6f select.

• Brand Name: NEURON 6F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5710647
• Report Number: 3005168196-2016-00761
• Device Sequence Number: 10930256
• Product Code: DQY
• UDI-Device Identifier: 00814548012070
• UDI-Public: 00814548012070
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2016

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: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: PNS6F125SIM
• Device Lot Number: F65201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2016
• Initial Report FDA Received Date: 06/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1