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

Catalog Number	PNS6F125SIM
Medical Device Problem Codes	Sticking (1597); Difficult to Advance (2920); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) using a neuron 6f select catheter (6f select).During the procedure, while advancing a 6f select through a neuron max 6f 088 long sheath (neuron max), the physician experienced resistance and the 6f select wouldn't advance smoothly through the neuron max.The physician stated that the 6f select required unusual force to advance and was almost impossible to turn and felt unusually sticky.The 6f select was flushed before use and after the initial recognition of the issue.However, the physician was still unable to advance it and therefore, it was removed.No visible damage was observed on the 6f select after removal.Thereafter, the procedure was completed using the same neuron max and other manufacturer's catheters.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: 5951145
• Report Number: 3005168196-2016-01323
• Device Sequence Number: 598955
• 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): 08/18/2016

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 Expiration Date: 06/02/2019
• Device Catalogue Number: PNS6F125SIM
• Device Lot Number: F69593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2016
• Initial Report FDA Received Date: 09/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR