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

Catalog Number	PND6F1056M
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for medical procedure, the hospital staff found that the tip of a neuron 6f 053 delivery catheter (neuron 053) was kinked upon removal from the packaging.The damaged neuron 053 was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new neuron 053.
Additional Manufacturer Narrative
Results: the neuron 6f 053 delivery catheter (neuron 053) was ovalized approximately 102.0 cm from the hub and kinked in multiple locations throughout its length.Conclusions: evaluation of the returned device revealed that it was ovalized in the distal shaft.This damage may have occurred due to forceful gripping of the distal tip of the device during removal from the packaging.The kinks observed throughout the catheter were likely incidental and may have occurred during packaging for return to penumbra.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.

• 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: 7166889
• Report Number: 3005168196-2018-00053
• Device Sequence Number: 1823082
• Product Code: DQY
• UDI-Device Identifier: 00814548010113
• UDI-Public: 00814548010113
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 12/06/2017
• Report Date (Section F): 01/01/2005

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: 06/08/2020
• Device Catalogue Number: PND6F1056M
• Device Lot Number: F77579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 02/13/2018; 01/14/2005
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 03/15/2018; 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005