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

Catalog Number	PNS6F125SIM
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2017
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
The patient was undergoing a medical procedure using a neuron 6f select catheter (6f select).During the procedure, the physician was unable to advance the 6f select into a neuron max 6f 088 long sheath (neuron max).It was reported that the 6f select did not fit into the neuron max.Therefore, the procedure was completed using another 6f select and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
There was no visible damage to the neuron 6f select catheter (6f select).The outer diameter (od) of the 6f select was measured using a ring gauge and found to be within specification.Evaluation of the returned device revealed that the 6f select od was within specification.The od of the 6f select was measured with a ring gauge and found to be within specification.Further evaluation of the returned device revealed that the 6f select was able to be advanced through a demonstration neuron max 6f 088 long sheath (neuron max) and out of the distal tip without an issue.The root cause of the reported issue that the 6f select was not fitting into the neuron max could not be determined.The neuron max referred to 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.

• Brand Name: NEURON 6F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7242797
• Report Number: 3005168196-2018-00275
• Device Sequence Number: 1222699
• Product Code: DQY
• UDI-Device Identifier: 00814548012070
• UDI-Public: 00814548012070
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083125
• 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,Followup
• Report Date (Section B): 01/08/2018

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: 06/18/2020
• Device Catalogue Number: PNS6F125SIM
• Device Lot Number: F77744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR