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

Model Number	SEP6
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
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 to treat a bilateral critical ischemia of the external iliac artery using an indigo system aspiration catheter 6 (cat6) and an indigo system separator 6 (sep6).During the procedure the physician completed approximately ten passes using the cat6 and sep6.Upon removal of the cat6 and the sep6, it was noticed that the bulb of the sep6 was missing.It was reported that the physician could not locate the bulb of the sep6 by sight or via fluoroscopy.The physician continued the procedure using an indigo system aspiration catheter 8 (cat8) and an indigo system separator 8 (sep8).It was reported that although the indigo system aspiration catheters unclogged the arteries, the arteries re-clogged just as quickly due to an already organized thrombus.The physician decided to end the procedure at this point.The patient was then put on a curative heparin therapy.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned sep6 confirmed that the bulb was fractured off the separator¿s distal end.Evaluation also revealed the sep6 core wire was fractured, and the support coil winds were unraveled.It was reported that the device was used for multiple passes.If the device is manipulated against tough clot burden or retracted against resistance, the device may fatigue and subsequently fracture.Penumbra products 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: DXE
• 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: 13636712
• Report Number: 3005168196-2022-00087
• Device Sequence Number: 20134008
• Product Code: DXE
• UDI-Device Identifier: 00814548016146
• UDI-Public: 00814548016146
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022
• 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: 05/05/2024
• Device Model Number: SEP6
• Device Catalogue Number: SEP6
• Device Lot Number: F106044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/01/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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: 64 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005