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

Model Number	CAT7DKIT-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the indigo aspiration system include, but are not limited to, distal embolization, hematoma or hemorrhage at the site, inability to completely remove thrombus, including death.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2021-00972.
Event or Problem Description
On (b)(6) 2021, the patient was undergoing a thrombectomy procedure in the left iliac artery using an indigo system aspiration catheter 7 (cat7).During the procedure, the rotating hemostasis valve (rhv) broke when tightening it and was unable to form a seal.Therefore, the rhv was removed.The procedure was completed by placing the tubing directly on the back of the cat7 to finish the last pass, and a new rhv was not used.It was reported that distal embolization was noted after aspiration with the cat7.There were no reported complications during the procedure.The patient was given ia rtpa, and a balloon angioplasty performed.This event was resolved the next day on (b)(6) 2021.The patient had improved from baseline.The peripheral/ distal embolization was reported to be a non-serious adverse event with a definite relationship to the cat7 and the index procedure.

• 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: 11972204
• Report Number: 3005168196-2021-01294
• Device Sequence Number: 19891026
• Product Code: QEW
• UDI-Device Identifier: 00815948023970
• UDI-Public: 00815948023970
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 04/07/2021
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2024
• Device Model Number: CAT7DKIT-A
• Device Catalogue Number: CAT7DKIT
• Device Lot Number: C25027
• 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: 04/07/2021
• Initial Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005