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

Catalog Number	PNS6F125BER
Medical Device Problem Codes	Physical Resistance (2578); Difficult to Advance (2920)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: there was no visible damage to the neuron 6f select catheter (6f select).The device was deemed within specification for outer diameter (od) after testing it on the ring gauge fixture.Conclusion: evaluation of the returned 6f select revealed it was able to be advanced into a neuron max 6f 088 long sheath (neuron max) with moderate resistance.Resistance was observed when the 6f select distal joint passed through the neuron max hub.After this resistance was overcome, the catheter advanced smoothly through the neuron max.The od was found to be within specification when tested with the ring gauge fixture.The root cause of this resistance could not be determined.The neuron max cited in the complaint was not returned for evaluation.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.
Event or Problem Description
During preparation for a medical procedure, the physician experienced resistance while attempting to advance a neuron 6f select catheter (6f select) into a neuron max 6f 088 long sheath (neuron max) on the back table.It was reported that the physician made several attempts to load the 6f select into the neuron max and even though it could be forced through, the 6f select did not move freely.Therefore, the 6f select was removed and the procedure was completed using a neuron select catheter 5f (5f select) and the same neuron max.

• Brand Name: NEURON 6F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6977840
• Report Number: 3005168196-2017-01836
• Device Sequence Number: 19115372
• Product Code: DQY
• UDI-Device Identifier: 00814548012094
• UDI-Public: 00814548012094
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2017

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: 02/22/2020
• Device Catalogue Number: PNS6F125BER
• Device Lot Number: F74561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1