MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 5F SELECT CATHETER; DQY

Catalog Number	PNS5F130BER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: the neuron 5f select catheter (5f select) was fractured approximately 123.0 cm from the hub.There was no gross yielding proximal or distal to the fracture.The non-penumbra sheath was kinked in multiple locations along the shaft conclusions: evaluation of the returned select revealed it was fractured at the proximal and distal shaft junction.This type of damage typically occurs due to improper handling during use.If the 5f select is forcefully handled at an angle during insertion into patient anatomy, damage such as this may occur.The kinks on the non-penumbra sheath were likely incidental, and may have occurred during packaging the devices for return.Penumbra catheters are 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
The patient was undergoing a thrombectomy procedure using a neuron 5f select catheter (5f select).During the procedure, in an attempt to advance the 5f select through the iliac artery and into the aorta, the physician advanced the 5f select through a non-penumbra sheath; however, the tip of the 5f select broke off in the patient before the physician reached the arch.Therefore, a snare device was used to remove the broken tip of the 5f select from the aorta.The procedure was completed using a new 5f select and the same non-penumbra sheath.There was no report of an adverse effect to the patient.

• Brand Name: NEURON 5F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6016792
• Report Number: 3005168196-2016-01443
• Device Sequence Number: 16603912
• Product Code: DQY
• UDI-Device Identifier: 00814548010212
• UDI-Public: 00814548010212
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/20/2019
• Device Catalogue Number: PNS5F130BER
• Device Lot Number: F70201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2016
• Initial Report FDA Received Date: 10/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR