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

Catalog Number	PNS5F120H1
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: the neuron 5f select catheter (5f select) was fractured approximately 117.0 cm from the hub.The distal segment of the fractured select was kinked approximately 7.0 cm from the distal tip.Conclusions: evaluation of the returned device revealed it was fractured in the distal shaft.This type of damage typically occurs due to improper handling during use.If the select is forcefully handled at an angle during insertion into patient anatomy, damage such as this may occur.Further evaluation revealed a kink in the distal segment of the fractured select.This damage likely occurred due to the snare used to remove the catheter tip.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 medical procedure treating an abdominal aortic aneurysm endoleak (aaa endoleak) using a neuron 5f select catheter (5f select).During the procedure, the physician advanced the 5f select through another manufacturer's sheath without experiencing resistance.However, while torquing the 5f select into the right common iliac artery, the hospital technologist believed that there was a kink in the 5f select.Therefore, the physician stepped back onto fluoroscopy and noticed that the entire black tip of the 5f select had separated from the rest of the catheter and was floating in the aorta.The physician then immediately withdrew the 5f select and removed the intact detached tip from the patient using a snare device.The procedure was completed using a new 5f select, multiple other catheters and the same sheath.It was reported the patient's anatomy was tortuous which the physician believed may have caused the 5f select to break.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: 5901513
• Report Number: 3005168196-2016-01232
• Device Sequence Number: 10901792
• Product Code: DQY
• UDI-Device Identifier: 00814548010199
• UDI-Public: 00814548010199
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/28/2016

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: 06/13/2019
• Device Catalogue Number: PNS5F120H1
• Device Lot Number: F70102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2016
• Initial Report FDA Received Date: 08/24/2016
• 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: 79 YR