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

Catalog Number	PND6F1056M
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the distal tip of the neuron 6f 053 delivery catheter (neuron 053) was kinked in multiple locations.Conclusions: evaluation of the returned device revealed that the distal tip of the neuron 053 was kinked in multiple locations.If the device is manipulated with force at extreme angles during removal from the packaging, this type of damage may occur.Penumbra catheters 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
During preparation for a medical procedure, the hospital staff noticed that the tip of a neuron 6f 053 delivery catheter (neuron 053) was bent upon removal from the packaging.The bent tip of the neuron 053 was found prior to use and therefore, the neuron 053 was not used for the procedure.The procedure was completed using a new neuron 053.

• 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: 5667467
• Report Number: 3005168196-2016-00687
• Device Sequence Number: 18853940
• Product Code: DQY
• UDI-Device Identifier: 00814548010113
• UDI-Public: 00814548010113
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 04/20/2016

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: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: PND6F1056M
• Device Lot Number: F63233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2016
• Initial Report FDA Received Date: 05/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1