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

Catalog Number	PNS5F130SIM
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: the neuron select 5f select catheter (5f select) was fractured approximately 123.0 cm from the hub.There was no visible yielding of the catheter shaft materials proximal or distal to the fracture.The distal segment of the 5f select was kinked near its distal tip.The 5f select was fractured and therefore, could not be tested for torquing or positioning within a system.Conclusions: evaluation of the returned device revealed that the 5f select was fractured.This damage may have occurred due to forceful manipulation and torquing of the 5f select during navigation of patient anatomy.There was no visible yielding of the catheter shaft materials proximal or distal to the fracture.Further evaluation revealed that the distal segment of the 5f select was kinked near the distal tip.This damage may have occurred due to forceful manipulation during navigation.The snare device used to retrieve the fractured segment from patient anatomy may have also contributed to this damage.The neuron max mentioned in the complaint was not returned for evaluation.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 to place a stent in the carotid artery using a neuron select 5f select catheter (5f select).During the procedure, the physician did not mention any resistance while using the 5f select; however, while torquing the 5f select to conform to the aortic arch, the physician noticed that the distal tip of the 5f select came off in the patient¿s body.Therefore, the physician used a snare device to remove the detached tip after hours of trying.The carotid stent was then successfully placed and the procedure was completed.There was no report of an adverse effect to the patient.

• 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: 7006202
• Report Number: 3005168196-2017-01954
• Device Sequence Number: 1273038
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 00814548010236
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K083125
• 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): 10/13/2017

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: 05/29/2020
• Device Catalogue Number: PNS5F130SIM
• Device Lot Number: F77386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/07/2017
• 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
• Patient Age: 67 YR