MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 8; QEW

Model Number	SEP8-B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) of the popliteal and the tibio peroneal trunk using an indigo system aspiration catheter 7 (cat7), a lightning aspiration tubing (lightning) and an indigo system separator 8 (sep8).During the procedure, the physician completed multiple passes using the cat7 and sep8.Next, the sep8 bulb was noticed to be sheared off in the patient based on fluoroscopic imaging.Subsequently, the physician attempted to aspirate the sep8; however, the sep8 could not be removed.Therefore, the sep8 was removed via open surgical embolectomy.It was reported that the surgical embolectomy was required regardless of the sep8 bulb breaking off because the entire clot burden could not be aspirated with the cat7.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned sep8 confirmed that the bulb was fractured off the distal tip of the delivery wire.If the sep8 is repeatedly manipulated against resistance in tough clot burden, the device may become fatigued.If the device is continued to be manipulated against resistance after fatigued, it may subsequently fracture.Penumbra separators 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 8
• 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: 13672620
• Report Number: 3005168196-2022-00100
• Device Sequence Number: 19998346
• Product Code: QEW
• UDI-Device Identifier: 00815948022980
• UDI-Public: 00815948022980
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161523
• 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): 05/09/2022
• 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 Model Number: SEP8-B
• Device Catalogue Number: SEP8
• Device Lot Number: F102075
• 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: 02/08/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 05/09/2022
• 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: 22 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005