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

Catalog Number	PND6F10512
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron 6f 053 delivery catheter (neuron 053) was ovalized on its distal shaft approximately 89.0 and 98.0 cm from the hub.Conclusions: evaluation of the returned neuron 053 revealed multiple ovalizations on its distal shaft.These ovalizations were likely a result of forcefully gripping or otherwise mishandling the device during preparation for use.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
During preparation for a medical procedure, the physician noticed that a neuron 6f 053 delivery catheter (neuron 053) was kinked on the back table.The damaged neuron 053 was found prior to use and therefore, was not used in the procedure.The procedure was completed using another catheter.

• 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: 7299059
• Report Number: 3005168196-2018-00419
• Device Sequence Number: 19145049
• Product Code: DQY
• UDI-Device Identifier: 00814548010083
• UDI-Public: 00814548010083
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/01/2018

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: 09/07/2018
• Device Catalogue Number: PND6F10512
• Device Lot Number: F65592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1