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

Catalog Number	SEP8
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned sep8 confirmed that the tip distal to the bulb was fractured off the delivery wire.If the sep8 is repeatedly manipulated through tough clot, the distal tip may become fatigued and damage such as a fracture may occur.The fractured distal tip was not returned for evaluation.The reported kink on the remaining wire distal to the bulb of the sep8 could not be confirmed.Further evaluation of the sep8 revealed a kink on the pusher wire.This damage was incidental to the complaint.Penumbra separators 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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a medical procedure in the right popliteal vein using an indigo system separator 8 (sep8) and an indigo system aspiration catheter 8 (cat8).It should be noted that the patient''s anatomy was tortuous.During the procedure, the physician completed three passes in the target location using the sep8 and the cat8 and experienced resistance while using the sep8 during all three passes.While making the next pass, the physician experienced resistance while advancing the sep8 and subsequently visualized under fluoroscopy that a piece of the wire distal to the bulb of the sep8 had fractured and remained in the target location.The physician also observed that the remaining wire distal to the bulb of the sep8 was kinked.The physician then used the cat8 and made several attempts to aspirate the wire; however, the piece of the wire distal to the bulb of the sep8 could not be removed and was stuck in the patient''s vessel.Therefore, the physician decided to allow the piece of the wire distal to the bulb of the sep8 to remain in the patient.The procedure was completed using the same cat8.

• 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: 18681934
• Report Number: 3005168196-2024-00046
• Device Sequence Number: 20667309
• Product Code: QEW
• UDI-Device Identifier: 00815948022980
• UDI-Public: 815948022980
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 02/09/2024
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2026
• Device Catalogue Number: SEP8
• Device Lot Number: H00002091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• 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: 01/18/2024
• Initial Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005