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

Catalog Number 4MAXC

Device Problems Fracture (1260); Physical Resistance/Sticking (4012)

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

Event Date 03/29/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.

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), a non-penumbra sheath and a guidewire.It should be noted that the patients anatomy was tortuous.During the procedure, the physician successfully completed two passes with the 4maxc.Next, while advancing the 4maxc over the guidewire towards the target location, the physician experienced resistance and decided to remove the 4maxc.Upon removal of the 4maxc, the physician found that the 4maxc was fractured at the mid-shaft and connected by the inner wire braiding.Therefore, the 4maxc was no longer used in the procedure.The procedure was completed using a new 4maxc, a new guidewire, and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned 4maxc confirmed that the catheter was fractured.If the 4maxc is advanced against resistance, damage such a kink and subsequent fracture may occur.Based on the reported complaint, the patient anatomy was tortuous.The tortuous anatomy may have contributed to resistance during advancement.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.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM 4MAX REPERFUSION CATHETERER
• 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: 16921588
• MDR Text Key: 315132102
• Report Number: 3005168196-2023-00224
• 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,Followup
• Report Date: 01/01/2005,05/30/2023

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: 4MAXC
• Device Lot Number: F113888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2023
• 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: 04/19/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2022
• 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: 72 YR
• Patient Sex: Male