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

Catalog Number RED72

Device Problems Fracture (1260); Stretched (1601); Physical Resistance/Sticking (4012)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

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 common carotid artery (cca) using a penumbra system red 72 reperfusion catheter (red72), a non-penumbra balloon guide catheter, and a non-penumbra short introducer sheath.During the procedure, the physician placed the balloon guide catheter using the short introducer sheath below the bifurcation of the cca via femoral access.A contrast run was then performed, and the physician advanced the red72 towards the thrombus for the first pass without a guidewire or an intermediate catheter.It was reported that the red72 bent over at the distal length and the physician retracted the red72 to straighten it.The physician moved the balloon guide catheter upwards then inflated the balloon.While retracting the red72 through the balloon guide catheter under aspiration, the physician experienced resistance.Upon removal of the red72, the physician noticed that the distal segment was stretched and fractured.It was observed under fluoroscopy that the red72 distal fragment was located parallel to the balloon guide catheter in the opposite direction.The physician then used a 50cc syringe to manually aspirate slowly with caution the distal fragment of the red72 into the balloon guide catheter and then removed the guide catheter from the short introducer sheath.The procedure was completed using a penumbra system red 62 reperfusion catheter (red62) and a non-penumbra long introducer sheath via femoral puncture on the contralateral side.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2024-00122.Evaluation of the returned red72 confirmed that the catheter was fractured.Stretching was present near the fractured location.If the red72 was retracted against resistance, damage such as stretching and subsequent fracture may occur.If a guidewire is not utilized during advancement of the red72, the catheter shaft may kink and contribute to resistance during use.Further evaluation revealed kinks along the catheter shaft.This damage was incidental to the reported complaint and may have occurred during packaging of the device 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.

Event Description

The patient was undergoing a thrombectomy procedure in the common carotid artery (cca) using a penumbra system red 72 reperfusion catheter (red72), a non-penumbra balloon guide catheter, and a non-penumbra short introducer sheath.During the procedure, the physician placed the balloon guide catheter using the short introducer sheath below the bifurcation of the cca via femoral access.A contrast run was then performed, and the physician advanced the red72 towards the thrombus for the first pass without a guidewire or an intermediate catheter.It was reported that the red72 prolapsed at the distal length and the physician retracted the red72 to straighten it.The physician moved the balloon guide catheter upwards then inflated the balloon.While retracting the red72 through the balloon guide catheter under aspiration, the physician experienced resistance.Upon removal of the red72, the physician noticed that the distal segment was stretched and fractured.It was observed under fluoroscopy that the red72 marker was located proximal to the balloon guide catheter distal tip outside of the guide catheter.The physician then used a 50cc syringe to manually aspirate the distal fragment of the red72 into the balloon guide catheter and then the guide catheter was removed.The procedure was completed using a penumbra system red 62 reperfusion catheter (red62) and a non-penumbra long introducer sheath via femoral puncture on the contralateral side.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: 19038298
• MDR Text Key: 339325959
• Report Number: 3005168196-2024-00122
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023925
• UDI-Public: 815948023925
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 01/01/2005,05/12/2024

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: RED72
• Device Lot Number: H00003739
• 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: 03/05/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 05/13/2024
• 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