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

Catalog Number	PNS6F125BER
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for a thrombectomy procedure the physician was unable to advance a neuron select catheter 6f (6f select) through the hub of a neuron max 088 (neuron max) on the back table.The physician noticed a slight bulge at the distal end near the transition of the 6f select.The damaged 6f select was found prior to use; therefore, it was never used.The procedure was completed using a new 6f and the same neuron max.There was no patient involved.
Additional Manufacturer Narrative
Results: there was no visible damage to the neuron 6f select (select).Conclusions: evaluation of the returned device revealed that the select was out of specification.A ring gauge was advanced and withdrawn over the select, and excessive resistance was experienced.The root cause of this failure could not be determined.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.

• Brand Name: NEURON 6F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5983225
• Report Number: 3005168196-2016-01378
• Device Sequence Number: 16163846
• Product Code: DQY
• UDI-Device Identifier: 00814548012094
• UDI-Public: 00814548012094
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2016

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: 04/05/2019
• Device Catalogue Number: PNS6F125BER
• Device Lot Number: F68796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 01/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1