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

Catalog Number	SEP7D
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/02/2024
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 a large thrombus in the arteriovenous fistula (avf) using an indigo system separator 7d (sep7d), indigo system aspiration catheter 7d (cat7d), non-penumbra catheter, and a non-penumbra sheath.During the procedure, the physician was experiencing resistance while advancing the sep7d to remove a lot of clot burden in the target location.After approximately halfway through the procedure, the physician noticed a radiopaque object under fluoroscopy.Therefore, the cat7d and sep7d was removed.Subsequently, upon inspecting distal end of the sep7d on the back table, the physician noticed the wire distal to the bulb of the sep7d had fractured.It was reported that the physician believes the fractured wire distal to the sep7d bulb came in contact with the stent struts from a previously placed stent in the cephalic arch and migrated into the pulmonary artery.The physician decided to leave the fractured wire of the sep7d in the vessel.The physician determined the wire was small enough and believed there was no risk to the patient.The procedure was completed using a balloon catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned sep7d confirmed the wire was fractured distal to the bulb.This type of damage typically occurs if the device is repeatedly advanced against tough clot burden.The core wire and wrapping wire may become kinked and may subsequently fracture.The reported interaction with a previously placed stent may have contributed to the fracture.During evaluation, the sep7d was advanced through a demonstration cat7d without an issue.Penumbra catheters are 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.

• Brand Name: INDIGO SYSTEM SEPARATOR 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: 20091687
• Report Number: 3005168196-2024-00290
• Device Sequence Number: 7810882
• Product Code: QEW
• UDI-Device Identifier: 00815948023994
• UDI-Public: 00815948023994
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 10/08/2024
• 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: 09/21/2025
• Device Catalogue Number: SEP7D
• Device Lot Number: H00001188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/02/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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: 68 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005