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

Catalog Number	PNS5F130H1
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2017
Type of Reportable Event	Serious Injury
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 in the right carotid artery using a neuron select catheter 5f (5f select).During the procedure, while advancing the 5f select within the patient to guide the neuron max to the target location in the high cervical artery, the distal tip of the 5f select broke within the aorta artery.The physician wanted to take care of the stroke first, so he used a reperfusion catheter and microcatheter with the same neuron max to remove the thrombus.The broken 5f select tip was then removed from the patient using a snare device and the procedure was completed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron select 5f select catheter (5f select) was fractured approximately 124.0 cm from the hub.The fractured distal tip was ovalized approximately 6.5 cm from the distal tip.Conclusions: evaluation of the returned device confirmed that the distal tip of the 5f select was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully handled at extreme angles while maneuvering within the patient anatomy, damage such as this may occur.Further evaluation of the returned device revealed that the fractured distal tip was ovalized.This damage likely occurred when the device was snared during removal from the patient.The neuron max, reperfusion catheter, and microcatheter described in the complaint were not returned 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 SELECT 5F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6662375
• Report Number: 3005168196-2017-00981
• Device Sequence Number: 197667
• Product Code: DQY
• UDI-Device Identifier: 00814548010229
• UDI-Public: 00814548010229
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/24/2017

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: 06/07/2019
• Device Catalogue Number: PNS5F130H1
• Device Lot Number: F70001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 08/29/2017
• 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