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

Catalog Number	PNS6F125BER
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	07/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the 6f select was ovalized approximately 118.0 cm from the hub.The 6f select outer diameter (od) could not be measured using the ring gauge due to the ovalization in the catheter shaft.Conclusions: evaluation of the returned 6f select revealed that the catheter was ovalized.If the device is forcefully gripped during insertion or preparation, damage such as this may occur.The ovalization in catheter shaft likely contributed to the resistance experienced and prevented the 6f select from tracking through the neuron max during the procedure.The neuron max identified in the complaint was not returned to penumbra for evaluation.Penumbra catheters are visually 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 or Problem Description
The patient was undergoing a medical procedure in the middle cerebral artery (mca) using a neuron 6f select catheter (6f select).During the procedure, while attempting to advance a 6f select through a neuron max 6f 088 long sheath (neuron max), the physician experienced resistance and the 6f select would not track inside the neuron max; therefore, it was removed.The procedure was completed using another 6f select and the same neuron max.There was no report of an adverse effect to the patient.

• Brand Name: NEURON 6F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7785982
• Report Number: 3005168196-2018-01574
• Device Sequence Number: 13498054
• Product Code: DQY
• UDI-Device Identifier: 00814548012094
• UDI-Public: 00814548012094
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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
• Report Date (Section B): 07/16/2018
• 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: 05/08/2020
• Device Catalogue Number: PNS6F125BER
• Device Lot Number: F76968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005