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

Catalog Number CATRXKIT

Device Problem Fracture (1260)

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

Event Date 11/10/2023

Event Type  Injury  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.

Event Description

The patient was undergoing a medical procedure in the peroneal tibial artery using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath, and a guidewire.It was reported that the patient¿s popliteal artery was tortuous.During the procedure, the physician advanced the catrx using contralateral access to aspirate a previously fractured tip of a guidewire from the patient¿s vessel; however, the attempt was unsuccessful.Therefore, the catrx was removed.Upon removal, the catrx was noticed to be fractured at the midshaft.The fractured portion of the catrx was remaining in the patient¿s superficial femoral artery (sfa).The physician then performed a surgical cut down to remove the fractured portion of the catrx.The procedure ended at this point.

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:.Narrative/corrected data: the product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.H3 other text : placeholder.

• Brand Name: INDIGO SYSTEM CATRX 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: 18284735
• MDR Text Key: 329959269
• Report Number: 3005168196-2023-00542
• Device Sequence Number: 1
• Product Code: QEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220683
• 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: 01/01/2005,02/06/2024

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
• Was Device Available for Evaluation?: No
• 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: 11/10/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Sex: Male