MAUDE Adverse Event Report: INDIGO SYSTEM CAT 8 ASPIRATION CATHETER; DXE

Model Number	CAT8TORQ85KIT-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) and popliteal artery using an indigo system aspiration catheter 8 (cat8) and a guidewire.During the procedure, the physician completed multiple passes in the target vessel using the cat8.While torquing the cat8, the physician fractured the cat8 near the hub, and the hub of the cat8 separated from the catheter.Therefore, the cat8 was removed.The procedure was completed using a new cat8.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM CAT 8 ASPIRATION CATHETER
• Common Device Name: DXE
• MDR Report Key: 12741028
• Report Number: 3005168196-2021-02477
• Device Sequence Number: 4126781
• Product Code: DXE
• UDI-Device Identifier: 00815948022294
• UDI-Public: 00815948022294
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2021
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2024
• Device Model Number: CAT8TORQ85KIT-S
• Device Catalogue Number: CAT8TORQ85KIT
• Device Lot Number: H11148
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005