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

Model Number PND6F070956M

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

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

The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a neuron 6f 070 delivery catheter (neuron 070), a non-penumbra catheter and a non-penumbra stent retriever.During the procedure, the physician advanced the non-penumbra catheter through the neuron 070, then inserted the stent retriever through the non-penumbra catheter.After completing a pass using the solumbra technique, the physician attempted to pull the stent retriever into the non-penumbra catheter and retract both devices; however, the stent retriever and catheter became stuck within the neuron 070.Therefore, the neuron 070, non-penumbra catheter and stent retriever were removed together.Upon removal, it was noticed that the devices were twisted together.The procedure was completed using new devices.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the neuron 070 had bends along its proximal and mid-shaft.The device had multiple kinks and ovalizations along the distal shaft from approximately 90.0 ¿ 101.0 cm from the hub.Conclusions: evaluation of the returned neuron 070 revealed multiple kinks and ovalizations along the distal shaft.If the peel-away sheath, packaged with the neuron 070, is not properly utilized prior to advancement of the device into a parent catheter, damage such as kinks and ovalizations may occur.This damage likely contributed to the non-penumbra catheter and stent retriever becoming stuck within the neuron 070 during the procedure.During functional testing, a demonstration 5f select was unable to advance through the neuron 070 due to the damage on the distal shaft.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 070 DELIVERY CATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10499453
• MDR Text Key: 205886449
• Report Number: 3005168196-2020-01403
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548010076
• UDI-Public: 00814548010076
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2022
• Device Model Number: PND6F070956M
• Device Catalogue Number: PND6F070956M
• Device Lot Number: F92312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• 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: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR