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

Model Number	CAT7DKIT-A
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an arteriovenous (av) fistula using a rotating hemostasis valve (rhv), an indigo system aspiration catheter 7 (cat7) and an indigo system separator 7 (sep7).During the procedure, the physician made two passes using the cat7 and the sep7.After the second pass, the physician noticed that the rhv was leaking blood and would not hold any suction.Subsequently, the distal part of the rhv was found to be broken.Therefore, the rhv was removed.The procedure was completed by ballooning the target vessel.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat7d revealed that the luer connector was detached from the rhv body.If the device is forcefully handled during use, damage such as this may occur.This damage likely contributed to the rhv leaking and its inability to hold suction during the procedure.Further evaluation revealed that the cat7d catheter was undamaged.During functional testing, the rhv was reassembled by pushing the two pieces together with force.Then the rhv was tested by closing one rotor cap and plugging the other side and flushing with air while submerged in the decontamination solution, and no air was observed to be leaking from the rhv.Subsequently, the rhv was connected to the cat7d, and the returned sep7d was advanced and retracted through without an issue.Penumbra accessories are 100% visually inspected and functionally tested during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 7
• Common Device Name: 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: 12641268
• Report Number: 3005168196-2021-02295
• Device Sequence Number: 13806990
• Product Code: QEW
• UDI-Device Identifier: 00815948023970
• UDI-Public: 00815948023970
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K210083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021
• 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: 01/27/2024
• Device Model Number: CAT7DKIT-A
• Device Catalogue Number: CAT7DKIT
• Device Lot Number: C25069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• 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: 09/23/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005