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	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right common femoral artery (cfa) and the anterior tibial artery (ata) using an indigo system aspiration catheter 6 (cat6), an indigo system separator 6 (sep6), a non-penumbra sheath and a guidewire.It should be noted that the patient¿s anatomy was tortuous.During the procedure, the physician used a contralateral approach and experienced resistance while using the sep6 in the cfa due to organized thrombus and tortuosity of the iliac artery.It was reported that the thrombus in the cfa could not be aspirated.The physician changed to an ipsilateral approach and performed one to two passes in the ata using the cat6 and sep6.However, the physician also experienced resistance while using the sep6 in the ata and decided to remove the sep6 from the patient.Upon removal of the sep6, the physician found that the sep6 bulb was missing.The physician could not locate the sep6 bulb in the patient's body under fluoroscopy or within the cat6 or the penumbra engine canister (canister).The procedure was completed using the same cat6 and the same sheath.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Evaluation of the returned sep6 confirmed that the bulb was detached from the distal tip and revealed kinks on the pusher wire.If the sep6 is manipulated against tough clot burden, resistance may be encountered and if the device is repeatedly manipulated against resistance, the bulb may become detached, and the pusher wire may become kinked.The device was unable to be functionally tested for the reported issue due to the damage.Penumbra devices 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: 17769465
• Report Number: 3005168196-2023-00434
• Device Sequence Number: 12330473
• Product Code: QEW
• UDI-Device Identifier: 00814548016146
• UDI-Public: 814548016146
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160533
• 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,Followup
• Report Date (Section B): 10/16/2023
• 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: 12/06/2025
• Device Catalogue Number: SEP6
• Device Lot Number: H00001659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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 Sex: Male
• Date Report Sent to FDA: 01/01/2005