MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE 68 REPERFUSION CATHETER; NRY

Catalog Number 5MAXACE068

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

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

Event Date 04/16/2023

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.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), a guidewire, a microcatheter, and a short sheath.It should be noted that the patient''s anatomy was tortuous.During the procedure, the physician experienced resistance while advancing the ace68 towards the target location under guidance of the microcatheter and the guidewire.The physician was unable to completely retract the ace68 and subsequently, the physician noticed on the angiography images that ace68 was fractured at the distal end.Therefore, the physician removed the proximal segment of the ace68 by hand and used a snare to remove the distal portion of the ace68 from the patient.The procedure was completed using a new ace68, the same short sheath, and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the first returned ace68 revealed stretching and a fracture on the distal end.This damage typically occurs due to retraction against resistance.Further evaluation revealed a kink near the fracture.This may indicate the device became pinned within patient anatomy.This may have contributed to resistance that resulted in the stretching and subsequent fracture of the device.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 5MAX ACE 68 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: 17144570
• MDR Text Key: 317333923
• Report Number: 3005168196-2023-00279
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023956
• UDI-Public: 815948023956
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161640
• 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: 01/01/2005,08/18/2023

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 Expiration Date: 11/18/2023
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: H11443
• 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: 05/24/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• 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: 61 YR
• Patient Sex: Female