MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER; NRY

Model Number 4MAXC

Device Problems Break (1069); Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the left middle cerebral artery using a penumbra system ace 68 reperfusion catheter (ace68), a penumbra system 4max reperfusion catheter (4maxc), and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician aspirated clot in the left middle cerebral artery using the ace68.After performing an angiography, the physician found that there was thrombus in the p1 segment of the distal posterior cerebral artery and decided to use a 4maxc for aspiration.The physician flushed the 4maxc with water, advanced the 4maxc to the target location, and initiated aspiration twice; however, it was reported the suction force was low and the image was not clear.Upon removal of the 4maxc, the physician injected water into it and noticed there was a break at the distal end.The physician took a photo, and 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

Please note that the following section was incorrectly reported on the follow-up #01 mfr report: and is being corrected on this follow-up #02 1.Section h.Box 10.Additional narrative and/or corrected data.Evaluation of the returned 4maxc revealed a distal tip ovalization.This is likely the reported damage at the distal end.If the 4maxc is forcefully gripped or pinched, or is otherwise mishandled during use, damage such as a distal tip ovalization may occur.This damage likely contributed to the reported low aspiration during the procedure.Due to the damage, the device was unable to be functionally tested.Further evaluation of the device revealed a mid-shaft kink.This damage was likely incidental to the complaint and may have occurred during packaging for the device return.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.

Manufacturer Narrative

Evaluation of the returned 4maxc revealed a distal tip ovalization.This is likely the reported damage at the distal end.If the 4maxc is forcefully gripped or pinched, or is otherwise mishandled during use, damage such as a distal tip ovalization may occur.This damage likely contributed to the reported low aspiration during the procedure.The 4maxc was tested with a demonstration canister and pump, and low aspiration was observed while attempting to aspirate water through the catheter.Further evaluation of the device revealed a mid-shaft kink.This damage was likely incidental to the complaint and may have occurred during packaging for the device return.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 4MAX 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: 12903324
• MDR Text Key: 286062616
• Report Number: 3005168196-2021-02718
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 00814548012414
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/01/2005,01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2021
• Device Model Number: 4MAXC
• Device Catalogue Number: 4MAXC
• Device Lot Number: F86674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• 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
• Date Manufacturer Received: 01/14/2005
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2018
• 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: 81 YR
• Patient Sex: Female