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

Catalog Number	CAT7DKIT
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left arteriovenous fistula (avf) venous segment using an indigo system aspiration catheter 7 d (cat7 d) and a non-penumbra sheath.During the procedure, while advancing the cat7 d through the sheath, the physician was experiencing resistance and was unable to advance the cat7 d.Subsequently, the physician kinked the cat7 d at the transition zone and decided to remove it.However, while removing the cat7 d out from the sheath, the physician experienced resistance again and broke the cat7 d into two separate pieces approximately 10 to 15 centimeters from the distal end.It was reported that there was enough of the broken piece of the cat7 d out of from the sheath to hold onto to remove it.Therefore, the cat7 d was not used for the remainder of the procedure.The procedure was completed using a new cat7 d and a new non-penumbra sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Additional 510(k)# that also apply to this complaint: k210083.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.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 7D
• 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: 15263001
• Report Number: 3005168196-2022-00383
• Device Sequence Number: 17534299
• Product Code: QEW
• UDI-Device Identifier: 00815948023970
• UDI-Public: 815948023970
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K193595
• 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
• Report Date (Section B): 08/19/2022
• 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: 05/01/2025
• Device Catalogue Number: CAT7DKIT
• Device Lot Number: H00000143
• 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: 07/26/2022
• Initial Report FDA Received Date: 08/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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: 69 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005