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

Catalog Number	PND6F0701058
Medical Device Problem Codes	Collapse (1099); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/17/2019
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 a medical procedure, the hospital technician found that a neuron 6f 070 delivery catheter (neuron 070) was flattened while attempting to advance a guide wire through it.The damage to the neuron 070 was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new neuron 070.
Additional Manufacturer Narrative
Results: the neuron 6f 070 delivery catheter (neuron 070) was ovalized from approximately 103.0 through 106.0 and 108.5 cm from the hub.Conclusions: evaluation of the returned neuron 070 confirmed that the distal shaft was ovalized.This type of damage typically occurs if the peel-able sheath is not properly utilized prior to use or due to forceful handling.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.

• 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: 8629392
• Report Number: 3005168196-2019-01018
• Device Sequence Number: 2256629
• Product Code: DQY
• UDI-Device Identifier: 00814548010045
• UDI-Public: 00814548010045
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019
• 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: 09/03/2021
• Device Catalogue Number: PND6F0701058
• Device Lot Number: F85628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/24/2019
• 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