MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT RX ASPIRATION CATHETER; QEX,QEW

Catalog Number CATRXKIT

Device Problem Break (1069)

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

Event Date 08/12/2022

Event Type  Injury  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the peroneal artery post atherectomy using an indigo system catrx aspiration catheter (catrx), a 7fr non-penumbra sheath, and a guidewire (0.014¿).During the procedure, the physician successfully aspirated clot in the target vessel using the catrx.Upon removal of the catrx, the guidewire lumen was noticed to not be attached to the catheter, and the physician noticed under fluoroscopy that the guidewire lumen was still in the patient¿s superficial femoral artery (sfa).Subsequently, the physician made multiple attempts to retrieve the detached guidewire lumen from the patient using snare devices.However; they were unsuccessful.The patient was then transported to the operating room (or) for surgical removal of the detached guidewire lumen via cutdown.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned catrx confirmed that the catheter was fractured.Based on the damage at the fracture location, this catheter fracture was likely the result of an initial kink.If the catrx is manipulated at an extreme angle during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed a kink in the catheter shaft.This damage was incidental to the reported complaint and the root cause could not be determined.Penumbra catrx is 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.

• Brand Name: INDIGO SYSTEM CAT RX ASPIRATION CATHETER
• Type of Device: QEX,QEW
• 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: 15395388
• MDR Text Key: 299621948
• Report Number: 3005168196-2022-00413
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 814548017556
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163618
• 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: 01/01/2005,10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F00000136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• 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: 08/16/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male