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

Catalog Number	PNS6F125BER
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2017
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 thrombectomy procedure using a neuron select catheter 6f (6f select).During the procedure, while attempting to advance the 6f select through a neuron max 6f 088 long sheath (neuron max), the physician experienced resistance and the 6f select would not advance; therefore, it was removed.The procedure was completed using another catheter and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron select catheter 6f (6f select)(ber) was kinked approximately 57.0 cm from the hub.The 6f select (ber) had kinks from the packaging condition.The outer diameter (od) could not be measured due to the kinks in the 6f select (ber).Conclusions: evaluation of the first returned device revealed that the 6f select (ber) was kinked.This kink was likely incidental and may have occurred while packaging the device for return to penumbra.Due to this kink in the 6f select (ber), the root cause of the reported resistance experience and the 6f select not being able to be advanced through the neuron max could not be determined.Evaluation of the second returned device revealed that the 6f select (sim) was functional.The od of the 6f select was measured and found to be within specification.Then the 6f select was advanced through a demonstration neuron max and out of the distal tip with some resistance due to return packaging-related kinks.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 SELECT CATHETER 6F
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7162046
• Report Number: 3005168196-2018-00008
• Device Sequence Number: 19320729
• Product Code: DQY
• UDI-Device Identifier: 00814548012094
• UDI-Public: 00814548012094
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 12/05/2017

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: 06/25/2020
• Device Catalogue Number: PNS6F125BER
• Device Lot Number: F77872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1