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

Catalog Number 4MAXC

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 08/26/2022

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the right m2 segment of the middle cerebral artery (mca) using a penumbra system 4max reperfusion catheter (4maxc) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician placed the neuron max in the patient.Next, while advancing the 4maxc into the neuron max, the physician experienced resistance.Therefore, the physician decided to remove the 4maxc.Upon removal, the physician noticed that the mid-shaft of the 4maxc was broken.The procedure was completed using a new 4maxc and the same neuron max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned 4maxc confirmed a fracture on its mid-shaft.If the 4maxc is advanced at an extreme angle during use, damage such as a kink may occur.This damage likely contributed to the reported resistance during advancement.Subsequently, further manipulation of a kinked device may worsen to a fracture.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: 15457681
• MDR Text Key: 300798997
• Report Number: 3005168196-2022-00439
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 814548012414
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4MAXC
• Device Lot Number: F109492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• 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: 08/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2021
• 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: 63 YR
• Patient Sex: Male