MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 070 DELIVERY CATHETER; DQY

Catalog Number	PND6F0701058
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: upon first evaluation, the strain relief was offset.The strain relief was partially unwound by a penumbra investigator for further evaluation, and the neuron 6f 070 delivery catheter (neuron 070) was fractured approximately 1.0 cm from the hub.The neuron 070 was kinked approximately 16.0 and 70.0 cm from the hub, and ovalized approximately 2.0 cm from the distal tip.Conclusions: evaluation of the returned device revealed it was fractured under the strain relief.This type of damage typically occurs due to forceful handling of the neuron 070 during removal from the packaging or during insertion into a parent catheter or patient anatomy.Further evaluation revealed the neuron 070 was ovalized near the distal tip.This type of damage typically occurs due to forceful pinching or otherwise compressing the neuron 070 during insertion.Evaluation also revealed the neuron 070 was kinked.This damage was likely incidental and may have occurred during packaging for return.Neuron 070 devices are 100% visually inspected during in-process inspection.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 070 delivery catheter (neuron 070).During the procedure, while connecting the perfusion devices, the physician noticed that saline solution was leaking from the hub of the neuron 070 to the proximal shaft connection.Therefore, the neuron 070 was removed and the procedure was completed using another manufacturer's catheter.There was no report of an adverse effect to the patient.

• Brand Name: NEURON 6F 070 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5816843
• Report Number: 3005168196-2016-01049
• Device Sequence Number: 11032072
• Product Code: DQY
• UDI-Device Identifier: 00814548010045
• UDI-Public: 00814548010045
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2016

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: Physician
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: PND6F0701058
• Device Lot Number: F65734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2016
• Initial Report FDA Received Date: 07/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1