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

Model Number	SEP6
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 superficial femoral artery (sfa) to the popliteal and tibial arteries using an indigo system aspiration catheter 6 (cat6) and an indigo system separator 6 (sep6).During the procedure, the physician completed one pass using the cat6 and sep6.While retracting the sep6 out of the cat6, the physician experienced resistance and noticed that the distal end of the sep6 proximal to the bulb had broken off in the rotating hemostasis valve (rhv).Therefore, the physician removed the broken end of the sep6 by flushing the rhv.The physician attempted an additional pass using the same cat6 and rhv; however, the physician then decided to drip thrombolytics overnight.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 distal end.The observed damage likely occurred during retraction of the device.If the device is forcefully retracted against resistance, damage such as this may occur.The root cause of resistance during the procedure could not be determined.Further evaluation revealed that the coil winds were unraveled.This damage was likely a result of the bulb fracturing off the distal end.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.

• Brand Name: INDIGO SYSTEM SEPARATOR 6
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12450331
• Report Number: 3005168196-2021-01995
• Device Sequence Number: 17023322
• Product Code: QEW
• UDI-Device Identifier: 00814548016146
• UDI-Public: 00814548016146
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021
• 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: 11/24/2023
• Device Model Number: SEP6
• Device Catalogue Number: SEP6
• Device Lot Number: F102260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Date Report Sent to FDA: 01/01/2005