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

Catalog Number	SEP8
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
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 in the veins in the lower extremity using an indigo system aspiration catheter 8 (cat8) and an indigo system separator 8 (sep8).During the procedure, while removing a cat8 from the packaging, the physician found that the cat8 was ovalized at the distal length.The damage to the cat8 was found prior to use and therefore, the cat8 was not used in the procedure.The physician then opened a new cat8 and completed three passes using the cat8 and sep8.While making the next pass, the physician visualized under fluoroscopy that the wire distal to the bulb of the sep8 fractured.Therefore, the sep8 was removed from the patient and a snare device was used to remove the sep8 wire.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
Evaluation of the returned sep8 confirmed that the device was fractured distal to the bulb.If the sep8 is repeatedly manipulated against resistance, damage such as this may occur.Further evaluation of the device revealed that the wrapping wire was unraveled.This damage was incidental to the complaint and may have occurred during snaring the device to remove from the patient¿s body.Evaluation revealed the delivery wire was kinked.This damage is incidental to the reported complaint and may have been due to handling during use or during packaging for return to penumbra.Penumbra devices 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 (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 20874867
• Report Number: 3005168196-2024-00404
• Device Sequence Number: 8905078
• Product Code: QEW
• UDI-Device Identifier: 00815948022980
• UDI-Public: 00815948022980
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: 12/01/2025
• Device Catalogue Number: SEP8
• Device Lot Number: H00001608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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