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

Catalog Number	SEP8
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the atraumatic tip of the returned sep8 was fractured at approximately 149.0 cm from the proximal end.Conclusions: evaluation of the returned sep8 confirmed that the atraumatic tip distal to the bulb was fractured.If the sep8 is repeatedly manipulated through tough clot burden, damage such as this may occur.If the core wire fractures, the wrapping wire may fatigue and fracture if the device continues to be used.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right pulmonary artery using an indigo system separator 8 (sep8).During the procedure, the physician advanced and retracted the sep8 within an indigo system aspiration catheter 8 (cat8) to break up and aspirate the clot for approximately 20 minutes.It was reported that the physician intermittently encountered slight resistance while retracting the sep8 in the cat8.The physician then performed fluoroscopy visualization and noticed that the distal wire tip of the sep8 had separated from the bulb and remained in the patient's vessel.An attempt was made to aspirate the wire tip using the cat8; however, it was unsuccessful.Therefore, the physician decided to end the procedure and the wire tip remained in the patient.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9350126
• Report Number: 3005168196-2019-02144
• Device Sequence Number: 16844494
• Product Code: QEW
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161523
• 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
• Report Date (Section B): 10/23/2019
• 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: 01/13/2022
• Device Catalogue Number: SEP8
• Device Lot Number: F87934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• 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: 10/23/2019
• Initial Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005