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

Catalog 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	05/04/2022
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 proximal tibial vessels using an indigo system catrx aspiration catheter (catrx), indigo system separator 6 (sep6), indigo system aspiration catheter 6 (cat6), and non-penumbra sheath.During the procedure, the physician initially made approximately one to two passes using the catrx.It was reported that the physician then decided to switch to the cat6.There was no damage noted on the catrx.The physician inserted the cat6 and then experienced resistance while introducing the sep6 through the cat6; therefore, the cat6 was removed and flushed.The physician reinserted the cat6 and then reinserted the sep6; however, the physician still experienced resistance advancing the sep6 through the cat6.Subsequently, the physician made approximately two passes.While making the next pass, the physician was advancing the cat6, and the hospital technologist was advancing and retracting the sep6 when the hospital technologist noticed the bulb of the sep6 broke off and was lodged within the cat6.Therefore, the physician removed the catheter containing the broken bulb of the sep6 under aspiration and the bulb was flushed out.The procedure was completed using the same cat6 with aspiration and was satisfied with the results.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 delivery wire.If the sep6 is manipulated against resistance during use, damage such as this may occur.The root cause of resistance during the procedure could not be determined.Penumbra coils are visually 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 Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 14518954
• Report Number: 3005168196-2022-00233
• Device Sequence Number: 15085580
• Product Code: QEW
• UDI-Device Identifier: 00814548016146
• UDI-Public: 814548016146
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022
• 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: 11/17/2023
• Device Catalogue Number: SEP6
• Device Lot Number: F102076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• 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: 05/04/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• 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: 45 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005