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

Catalog Number RED72KIT

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/31/2023

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

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 non-penumbra sheath, and a guidewire.During the procedure, the physician completed one pass using the red72 and sheath.While reconnecting the red72 back to the iv drip, the physician noticed that the red72 was leaking at the proximal end, near the hub.Therefore, the red72 was removed.The procedure was completed using a penumbra system red 68 reperfusion catheter (red68) and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned red72 confirmed a leak coming from underneath the strain relief near the hub.Evaluation revealed a kink near the hub of the catheter and hole at the kinked location underneath the strain relief.This type of kink and a subsequent fracture typically occurs if the device is held at an angle during use.It was reported that the leak was noticed while reconnecting the red72 back to the iv drip during use.Further evaluation revealed multiple consecutive kinks along the distal shaft, and the distal tip was damaged.This damage is incidental to the reported complaint and typically occurs if the device is advanced against resistance during use.Based on the reported event, the root cause of resistance could not be determined.Penumbra devices are visually 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 sections were incorrectly reported on the follow-up #01 and are being corrected on this follow-up #02 mfr report: 3005168196-2024-00033.1.Section h.Box 6.Results code 3.2.Section h.Box 6.Results code 4 - should be blank 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: 18596949
• MDR Text Key: 334837045
• Report Number: 3005168196-2024-00033
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023949
• UDI-Public: 815948023949
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K211654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• 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: H00003737
• 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
• Date Manufacturer Received: 01/14/2005
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2023
• 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: 81 YR
• Patient Sex: Female