MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; QEW

Model Number	CAT6KIT-A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
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 popliteal artery using an indigo system aspiration catheter 6 (cat6), a non-penumbra guide sheath and a guidewire.It was noted that the patient anatomy was tortuous.During the procedure, the physician completed one pass using the cat6.While advancing the cat6 through a calcified lesion to make another pass, the physician kinked the proximal end of the cat6.Therefore, the cat6 was removed.The procedure was completed using a new cat6, a guidewire and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note, that the following sections were incorrectly reported on the initial mfr report.And is being corrected on this follow-up #xx mfr report.1.Section g: box 4, date received by manufacturer.H3 other text: placeholder.
Additional Manufacturer Narrative
H10/11: previous mdr submission indicated "please note that the following sections were incorrectly reported on the initial mfr report and is being corrected on this follow-up #xx mfr report.However, the follow-up #xx and mfr report# have been updated in this follow-up.Please note that the following sections were incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2021-02046.H3 other text: placeholder.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• 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: 12471746
• Report Number: 3005168196-2021-02046
• Device Sequence Number: 5156405
• Product Code: QEW
• UDI-Device Identifier: 00815948020405
• UDI-Public: 00815948020405
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192833
• 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,Followup
• Report Date (Section B): 12/22/2021
• 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: 11/02/2023
• Device Model Number: CAT6KIT-A
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F101684
• Was Device Available for Evaluation?: No
• 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: 08/24/2021
• Supplement Date Received by Manufacturer: 09/07/2021; 01/14/2005
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 11/19/2021; 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• 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: 65 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005