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

Catalog Number	SEP7D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/18/2025
Type of Reportable Event	Serious Injury
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 brachycephalic fistula using an indigo system separator 7d (sep7d), an indigo system aspiration catheter 7d (cat7d), and a non-penumbra introducer sheath.It was reported that the patient's anatomy was tortuous.During the procedure, the physician completed two passes in the target location using the sep7d and cat7d.The physician then observed under fluoroscopy that the wire distal to the bulb of the sep7d had fractured and was embedded in the vessel wall.Therefore, the sep7d was removed from the patient.The physician then attempted to aspirate the wire of the sep7d using the cat7d, without success.The physician decided to leave the wire of the sep7d in the patient.The procedure was completed using an indigo system separator 7 (sep7) and the same cat7d.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report: section h.Box 5.Labeled for single use.Evaluation of the returned indigo system separator 7d (sep7d) confirmed that the separator wire distal to the bulb was fractured.Evaluation also revealed damage to the separator bulb and pusher wire proximal to the bulb.This type of damage typically occurs if the sep7d is repeatedly manipulated into tough clot burden during use.The core wire and separator tip may fatigue and may subsequently fracture.Penumbra devices 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 (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21403824
• Report Number: 3005168196-2025-00043
• Device Sequence Number: 18478053
• Product Code: QEW
• UDI-Device Identifier: 00815948023994
• UDI-Public: 00815948023994
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K210083
• 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): 03/18/2025

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: 06/12/2026
• Device Catalogue Number: SEP7D
• Device Lot Number: H00003030
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male