MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 8; QEW

Catalog Number	SEP8
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right superior femoral artery (sfa) and the popliteal artery using an indigo system separator 8 (sep8), an indigo system aspiration catheter 8 (cat8), a stent, and a.035 guidewire.It was noted that the stent was implanted into the right sfa.During the procedure, the guidewire was advanced through the lesion of the target vessel and aspiration was turned on.The physician then advanced the sep8 and the cat8 to the target location.While manipulating the sep8 within the thrombus, the physician observed via fluoroscopy that the distal end of the sep8 had fractured off.After removing the proximal part of the sep8, the cat8 containing the fractured sep8 was removed under aspiration.It was reported that the sep8 was flushed out of the cat8 on the back table.The procedure was completed using a new sep8 and the same cat8.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right superior femoral artery (sfa) and the popliteal artery using an indigo system separator 8 (sep8), an indigo system aspiration catheter 8 (cat8), a stent, and a.035 guidewire.It was noted that the stent was implanted into the right sfa.During the procedure, the guidewire was advanced through the lesion of the target vessel and aspiration was turned on.After advancing the cat8 into the target location, the physician advanced the sep8 approximately one and a half centimeters out of the cat8.While manipulating the sep8 back and forth using a torque device within the thrombus, the physician observed via fluoroscopy that the distal end of the sep8 had fractured off.After removing the proximal part of the sep8, the cat8 containing the fractured sep8 was removed under aspiration.It was reported that the sep8 was flushed out of the cat8 on the back table.The procedure was completed using a new sep8 and the same cat8.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the distributor on 09/25/2023: section b.Box 5.Describe event or problem.Evaluation of the returned sep8 confirmed that the distal end of the sep8 was fractured.Evaluation revealed that the core wire and wrapping wire was fractured, and the winds were unraveled.The core wire may fatigue and may subsequently fracture if the device continues to be used after becoming damaged.The proximal fractured segment was not returned for evaluation.Penumbra separators are visually 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 8
• 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: 17724512
• Report Number: 3005168196-2023-00423
• Device Sequence Number: 7148702
• Product Code: QEW
• UDI-Device Identifier: 00815948022980
• UDI-Public: 815948022980
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023
• 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: 01/10/2026
• Device Catalogue Number: SEP8
• Device Lot Number: H00001872
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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: 82 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005