MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Catalog Number	PNML6F088804
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron max 6f 088 long sheath (neuron max) was ovalized approximately 62.0 thru 64.0 cm from the hub.Conclusions: evaluation of the returned device revealed that the neuron max was ovalized.This type of damage typically occurs due to improper handling during preparation or use.If the device is forcefully gripped or pinched during preparation for use, damage such as this may occur.A demonstration select catheter was attempted to be advanced through the returned neuron max.While advancing the select catheter through the neuron max resistance was encountered as the select catheter met the ovalization in the neuron max and the select catheter could not be advanced any further.The 5f select 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.
Event or Problem Description
During preparation for a medical procedure, it was noticed that a neuron max 6f 088 long sheath (neuron max) was kinked after flushing it and attempting to put a neuron select 5f select catheter (5f select) through it.Therefore, the neuron max was set aside and the procedure was completed using a new neuron max and the same 5f select.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7404708
• Report Number: 3005168196-2018-00729
• Device Sequence Number: 16291739
• Product Code: DQY
• UDI-Device Identifier: 00814548012216
• UDI-Public: 00814548012216
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111380
• 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
• Report Date (Section B): 03/12/2018

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: 06/25/2020
• Device Catalogue Number: PNML6F088804
• Device Lot Number: F77877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1