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

Catalog Number PND6F0701058

Device Problems Collapse (1099); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event 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.

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
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8629392
• MDR Text Key: 145738895
• Report Number: 3005168196-2019-01018
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548010045
• UDI-Public: 00814548010045
• Combination Product (y/n): Y
• PMA/PMN Number: K082290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1