MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Model Number	CAT8XTORQ115KIT-B
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
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.This report is associated with mfr report number: 3005168196-2020-01836.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left common iliac artery using indigo system aspiration catheter 8s (cat8s) and a non-penumbra sheath.During the procedure, while advancing the cat8 into the sheath, the physician experienced resistance, and the distal end of the cat8 kinked.Subsequently, the cat8 was removed.The physician continued with the procedure using a second cat8 and completed five passes.While attempting to make the next pass, the physician noticed the cat8 was unable to aspirate the thrombus.Therefore, the cat8 was removed.The procedure was completed using a new catheter and thrombolytic therapy.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10744552
• Report Number: 3005168196-2020-01837
• Device Sequence Number: 3180294
• Product Code: DXE
• UDI-Device Identifier: 00815948022485
• UDI-Public: 00815948022485
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 10/02/2020
• 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: 08/11/2023
• Device Model Number: CAT8XTORQ115KIT-B
• Device Catalogue Number: CAT8XTORQ115KIT
• Device Lot Number: H10685
• 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: 10/02/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Date Report Sent to FDA: 01/01/2005