MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number 3MAXC

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/26/2022

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max), a neuron select catheter 6f (6f select), a penumbra system ace 68 reperfusion catheter (ace68), a penumbra system 3max reperfusion catheter (3maxc) and a guidewire.During the procedure, the physician placed the neuron max in the patient using the 6f select.Then, the physician used the 3maxc to bring the ace68 to the front of the thrombus.After removing the 3maxc, the physician noticed that approximately three centimeters from the distal end of the 3maxc was missing.It was then noticed that the broken distal end of the 3maxc was near the site of the occlusion.Subsequently, the physician decided to start aspirating the thrombus using the ace68 and stent retriever.After successful recanalization of the vessel, the physician made multiple attempts to remove the broken distal end of the 3maxc using two different non-penumbra stent retrievers but was unsuccessful.The procedure ended at this point.There was no report of an adverse effect to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation of the returned 3maxc confirmed a fracture on its distal shaft.Evaluation also revealed the device was stretched proximal to the fracture location.This damage typically occurs if the device is forcefully retracted against resistance.If the device is retracted against resistance, the 3maxc may become stretched and subsequently fracture.Based on the reported event, the root cause of resistance could not be determined.The distal fractured segment was unable to be retrieved for evaluation.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: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 14575838
• MDR Text Key: 295681467
• Report Number: 3005168196-2022-00249
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 814548019956
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/27/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 3MAXC
• Device Lot Number: F107011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female