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

Catalog Number RED72KIT

Device Problems Break (1069); Unraveled Material (1664); Physical Resistance/Sticking (4012)

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

Event Date 08/23/2022

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2022-00426.

Event Description

The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a penumbra system 3max reperfusion catheter (3maxc), a guide catheter, and a 0.035¿ guidewire.During the procedure, the physician gained access to the target vessel via right radial artery using the guide catheter.Then, the physician completed one pass in the target vessel using the red72, 3maxc, and guide catheter.While retracting the red72 and 3maxc through the guide catheter, the physician experienced resistance and broke the red72 and 3maxc at the mid-shaft.It was also reported that both devices became unraveled at the mid-shaft and the guide catheter became kinked.The physician then advanced the guidewire into the 3maxc and red72 and removed both devices successfully.The procedure was completed using a new 3maxc, a 6fr non-penumbra catheter, and a new guide catheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned red72 confirmed that the catheter was fractured.Evaluation revealed stretching at the fracture site.If the red72 is retracted against resistance during use, the device may stretch and subsequently fracture.The root cause of resistance during the procedure could not be determined.Further evaluation revealed kinks in the distal fractured segment, and the supported coil winds unraveled and wrapped around the non-penumbra guidewire.This damage was incidental to the reported complaint and the root cause could not be determined.Evaluation of the returned 3maxc could not confirm that the catheter was fractured.Evaluation reveled bends along the distal shaft of the catheter.This damage was incidental to the reported complaint and the root cause could not be determined.The 3maxc was advanced through a demonstration red72 without an issue during evaluation.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.This report is associated with mfr report number: 1.3005168196-2022-00426.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: 15420398
• MDR Text Key: 306242756
• Report Number: 3005168196-2022-00425
• 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: 01/01/2005,10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• 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: F110887
• 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: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• 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