MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 053 DELIVERY CATHETER; DQY

Catalog Number	PND6F1056M
Medical Device Problem Codes	Break (1069); Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron 6f 053 delivery catheter (neuron 053) was ovalized approximately 99.0 cm and fractured approximately 100.0 cm from the hub.Conclusions: evaluation of the returned device revealed that the neuron 053 was ovalized and fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully gripped or pinched during insertion, damage such as an ovalization may occur.Further evaluation of the returned device revealed that the neuron 053 was fractured.Based on the complaint description, the physician believed that it happened at a kink in the proximal internal carotid artery (ica).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
The patient was undergoing a medical procedure using a neuron 6f 053 delivery catheter (neuron 053).During the procedure, the physician advanced the neuron 053 through a non-penumbra sheath and into the target location.The physician then noticed a hole or break in the neuron 053 when contrast was injected through it.The physician was unsure how the break occurred but believed that it happened at a kink in the proximal internal carotid artery (ica).After that, the physician noted a ¿break down¿ at the tip of a non-penumbra guidewire, which was retrieved using a snare device.It was reported that the breakage of the guidewire had nothing to do with any penumbra devices.The procedure was then completed using the same neuron 053 despite the fact that it was leaking.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that additional information was provided on 23 oct 2017, as this complaint was submitted to the fda by the user facility with the following reference number: mw5072698.

• Brand Name: NEURON 6F 053 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6963211
• Report Number: 3005168196-2017-01785
• Device Sequence Number: 11103745
• Product Code: DQY
• UDI-Device Identifier: 00814548010113
• UDI-Public: 00814548010113
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

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: No Information
• Device Expiration Date: 04/17/2020
• Device Catalogue Number: PND6F1056M
• Device Lot Number: F75720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR