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

Model Number	SEP8
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 popliteal to the common iliac vein using an indigo system separator 8 (sep8) and an indigo system aspiration catheter 8 (cat8).During the procedure, the physician completed two passes using the cat8 and sep8.During the third pass, it was noticed that no thrombus was being aspirated out after some time; therefore, the physician decided to remove the sep8.Upon removal, it was noticed that the bulb of the sep8 was missing.Under fluoroscopy, the physician searched for the bulb of the sep8; however, the physician did not find the bulb inside the patient.It was reported that the canister was emptied out because the physician suspected that the bulb of the sep8 might have been aspirated with the thrombus after breaking off from the sep8.The procedure was completed after aspirating a few more times using the same cat8.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10408933
• Report Number: 3005168196-2020-01207
• Device Sequence Number: 3120595
• Product Code: DXE
• UDI-Device Identifier: 00814548016153
• UDI-Public: 00814548016153
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K161523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2020
• 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: 06/05/2021
• Device Model Number: SEP8
• Device Catalogue Number: SEP8
• Device Lot Number: F83879
• Was Device Available for Evaluation?: No
• 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: 06/30/2020
• Initial Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005