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

Catalog Number RED72SDKIT

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

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned red72 confirmed a fracture on the distal shaft.Evaluation revealed stretching on both sides of the fracture.The distal fractured segment was ovalized and kinked.This indicates the distal portion of the red72 may have become pinned at some point during retraction.If the red72 is subsequently retracted against resistance, the device may become stretched and fracture.Some of the kinks on the distal fractured segment may have been due to snaring during the procedure.The sendit was unable to be retracted from the red72, and therefore, could not to be functionally tested.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.

Event Description

The patient was undergoing a thrombectomy procedure in the left m1 segment of the middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a sendit delivery device (sendit), a bmx96 access system (bmx96), and a non-penumbra guide catheter.It was reported the patient¿s anatomy was tortuous.During the procedure, the physician advanced the red72 and sendit to the target location and completed one pass.It was reported that the pass resulted in thrombolysis in cerebral infarction (tici) grade 2b.During the next pass, the physician experienced resistance and subsequently, the red72 fractured.The physician then removed the red72 against resistance.Upon removal, approximately twenty centimeters of the distal portion of the red72 was missing and remained in the internal carotid artery (ica).The physician then used a snare device and removed the remaining portion of the red72 from the patient¿s body.The procedure was completed using a new red72, a penumbra system red 43 reperfusion catheter (red43), the same sheath, and a non-penumbra microwire resulting in thrombolysis in cerebral infarction (tici) grade 3.There was no report of an adverse effect to the patient.

• 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: 17989117
• MDR Text Key: 327358822
• Report Number: 3005168196-2023-00476
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948025943
• UDI-Public: 815948025943
• 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
• Report Date: 01/01/2005,10/23/2023

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: RED72SDKIT
• Device Lot Number: F00006942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• 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: 09/28/2023
• Initial Date FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2023
• 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: 85 YR
• Patient Sex: Female