MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 6; QEW

Catalog Number	SEP6
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superior mesenteric artery (sma) using an indigo system separator 6 (sep6) and an indigo system aspiration catheter 6 (cat6).During the procedure, the physician advanced the cat6 and sep6 to the target vessel via femoral access and successfully performed a pass.It was reported that large clots were aspirated effectively.However, as the procedure progressed, the physician noticed that the sep6 was no longer effective and decided to remove it.Upon removal, the physician noticed that the bulb of the sep6 was partially fractured and only 1/8 of the bulb remained.It was reported that no fragments of the sep6 bulb could be located, and that the fragments may have been flushed out.The physician then used a second sep6 with the same cat6 to continue the procedure.After completing two passes in the target vessel using the sep6 and cat6, the bulb of the sep6 fractured within the cat6.Therefore, the sep6 and cat6 were removed from the patient, and the bulb of the sep6 was flushed out of the cat6.The procedure was completed using the same cat6 and the first sep6.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.
Additional Manufacturer Narrative
Evaluation of the returned indigo system separator 6 (sep6) confirmed that the separator bulb was fractured and revealed that the pusher wire was kinked near its distal end.If the sep6 is repeatedly manipulated through tough clot during use, damage such as this may occur.The fractured separator bulb was not returned for evaluation.Further evaluation of the sep6 revealed that the distal solder was not present on its distal end.This damage is incidental to the complaint and the root cause could not be determined.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 6
• 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: 22038038
• Report Number: 3005168196-2025-00161
• Device Sequence Number: 12790238
• Product Code: QEW
• UDI-Device Identifier: 00814548016146
• UDI-Public: 00814548016146
• Combination Product (Y/N): Y
• Initial Reporter Country: RP
• PMA/510(K) Number: K142870
• 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): 07/16/2025

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 Catalogue Number: SEP6
• Device Lot Number: H00005019
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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: 84 YR
• Patient Sex: Female