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

Catalog Number	SEP7
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis and has been evaluated.Evaluation of the returned sep7 confirmed that the wire was fractured distal to the bulb.This type of damage typically occurs if the sep7 is repeatedly manipulated against resistance during use.The wire may become fatigued, and damage such as a kink and subsequent fracture may occur.The complaint indicated that multiple passes with the sep7 were performed within the reported tortuous patient anatomy.Evaluation revealed that the bulb was intact and had kinks on the core wire.The kinks on the core wire were incidental to the reported 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superficial femoral artery using an indigo system separator 7 (sep7) and an indigo system aspiration catheter 7 (cat7).It should be noted that the patient''s anatomy was tortuous.During the procedure, the physician performed multiple passes in the target location using the cat7 and sep7.While making another pass, the physician observed under fluoroscopy that the sep7 had fractured in the popliteal artery.Therefore, the sep7 was removed from the patient and the fractured portion was successfully aspirated out using the cat7.The procedure was completed using a new sep7 and the same cat7.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 7
• 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: 19315742
• Report Number: 3005168196-2024-00179
• Device Sequence Number: 3063456
• Product Code: QEW
• UDI-Device Identifier: 00815948024014
• UDI-Public: 815948024014
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K210083
• 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): 05/14/2024
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2026
• Device Catalogue Number: SEP7
• Device Lot Number: H00003697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2024
• 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: 04/18/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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: 54 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005