MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 12 ASPIRATION CATHETER; QEW

Model Number	LITNG12HTORQ115-A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the femoral vein, iliac vein, and inferior vena cava (ivc) using an indigo system aspiration catheter 12 (cat12), an indigo system separator 12 (sep12), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician completed multiple passes on the left side target vessels using the cat12 and sep12.The physician then completed one pass on the right side target vessels using the cat12 and sep12.While removing the cat12 to flush, the physician noticed two kinks on the mid-shaft of the cat12.Therefore, the cat12 was removed.It was reported that suction with the cat12 was greatly decreased after multiple passes were completed.The procedure was completing using the same sep12, a new cat12, and a new rotating hemostasis valve (rhv).It should be noted that there was no issue with the first rhv.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT 12 ASPIRATION CATHETER
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12619377
• Report Number: 3005168196-2021-02261
• Device Sequence Number: 3586846
• Product Code: QEW
• UDI-Device Identifier: 00815948022577
• UDI-Public: 00815948022577
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202821
• 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): 10/12/2021
• 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: 04/18/2024
• Device Model Number: LITNG12HTORQ115-A
• Device Catalogue Number: LITNG12HTORQ115
• Device Lot Number: H11316
• 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: 09/17/2021
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005