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

Model Number	SEP8-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a deep vein thrombosis (dvt) in the femoral vein using an indigo system separator 8 (sep8), an indigo system aspiration catheter 8 (cat8) and a non-penumbra sheath.During the procedure, the physician used the sep8 with the cat8 several times to remove much of the existing thrombus.After approximately one hour, the physician observed that no thrombus was being aspirated out even though the sep8 was being used.The physician then noticed that the wire distal to the bulb of the sep8 broke off in the cat8.Therefore, the sep8 was removed and the broken wire of the sep8 was aspirated through the cat8 into the canister.The procedure was completed using a new sep8 with the same cat8 and sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the core wire and wrapping wire were fractured at the tip of the returned sep8 approximately 150.0 cm from the proximal end.Conclusions: evaluation of the returned sep8 confirmed that the core wire and wrapping wire distal to the bulb were fractured.If the sep8 is repeatedly manipulated through tough clot burden, damage such as a fractured core wire may occur.If the core wire fractures, the wrapping wire may fatigue and fracture.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 h3 other text : placeholder.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10061495
• Report Number: 3005168196-2020-00653
• Device Sequence Number: 11433042
• Product Code: DXE
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 04/27/2020
• 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: 06/23/2022
• Device Model Number: SEP8-A
• Device Catalogue Number: SEP8
• Device Lot Number: F91236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Date Report Sent to FDA: 01/01/2005