MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 7; QEW

Model Number	CAT7XTORQ130KIT-A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned cat7 confirmed that the catheter was kinked.If the cat7 is forcefully manipulated against resistance or is otherwise mishandled at extreme angles during use, damage such as kinks may occur.Penumbra catheters are 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.
Event or Problem Description
The patient underwent a thrombectomy procedure in the popliteal using an indigo system aspiration catheter 7 (cat7), a non-penumbra sheath, and a guidewire.It should be noted that the patient had tortuous iliacs and bifurcations.During the procedure, the physician completed a few passes using the cat7.While withdrawing the cat7 from the patient, the physician encountered resistance.After the cat7 was removed from the patient, the physician noticed the cat7 had kinked mid-shaft.The procedure was completed successfully at this point and no additional passes were required.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 7
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11574916
• Report Number: 3005168196-2021-00593
• Device Sequence Number: 3459938
• Product Code: QEW
• UDI-Device Identifier: 00815948021648
• UDI-Public: 00815948021648
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193595
• 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): 02/25/2021
• 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: 08/13/2023
• Device Model Number: CAT7XTORQ130KIT-A
• Device Catalogue Number: CAT7XTORQ130KIT
• Device Lot Number: F99529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• 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: 02/25/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005