MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER; NRY

Catalog Number RED72KIT

Device Problem Fracture (1260)

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

Event Date 10/26/2023

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the right internal carotid artery (ica) using a penumbra system red 72 reperfusion catheter (red72), a benchmark bmx96 access system (bmx96), a non-penumbra microcatheter, a non-penumbra stent retriever and a guidewire.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician used radial approach and completed the first pass with aspiration using the red72 and stent retriever.While removing the red72 after the first pass aspiration, the physician noticed unwinding of the red72 at the distal end.The physician removed all the catheters and switched to femoral access.The procedure was completed with two more passes using a non-penumbra sheath, a non-penumbra catheter, the same microcatheter and the same stent retriever.Thrombolysis in cerebral infarction (tici) grade 2b was achieved.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned red72 confirmed a fracture and revealed that the catheter was ovalized near the fractured location.If the parent device becomes kinked while the red72 is inserted, damage such as a kink/ovalization may occur.This damage may contribute to resistance during retraction.Forceful retraction against this resistance likely contributed to the fracture.Further evaluation revealed kinks and ovalization along the proximal shaft, and consecutive kinks along the distal fractured segment.The distal kinks were likely due to manipulation against resistance during the procedure.The proximal damage was likely incidental to the complaint and may have occurred during packaging for return to penumbra.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.

Manufacturer Narrative

Please note that the following section was inadvertently missed on the initial mfr report and is being reported on this follow-up #01 mfr report:3005168196-2023-00521.1.Section h.Box 6.Results code 4 (added results code) h3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM RED 72 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: 18172484
• MDR Text Key: 328890762
• Report Number: 3005168196-2023-00521
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 815948023932
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/14/2023

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: RED72KIT
• Device Lot Number: H00001805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• 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: 10/26/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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: 95 YR
• Patient Sex: Female