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

Catalog Number	PNS5F130SIM
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a medical procedure in the right middle cerebral artery (mca) using a neuron select catheter 5f (5f select).During the procedure, prior to advancement into the patient, the physician flushed the 5f select and attempted to advance a guidewire.However, the physician experienced resistance while advancing the guidewire and reported that it was unable to advance through the 5f select.The 5f select was therefore removed and was not used in the procedure.The procedure was completed using another 5f select.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned 5f select was ovalized from approximately 119.0 cm to 122.0 cm from the hub.Conclusions: evaluation of the returned 5f select revealed an ovalization on the distal shaft of the catheter.If the catheter is forcefully gripped or pinched during the procedure, the catheter may become ovalized.The ovalization on the catheter likely contributed to the reported resistance while advancing the guidewire.During functional testing, a test mandrel was unable to be advanced through the ovalized location on the 5f select.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 SELECT CATHETER 5F
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8525024
• Report Number: 3005168196-2019-00747
• Device Sequence Number: 2798798
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 00814548010236
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• 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): 03/20/2019
• Report Date (Section F): 01/01/2005

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: 01/02/2022
• Device Catalogue Number: PNS5F130SIM
• Device Lot Number: F87801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Date Report Sent to FDA: 01/01/2005