MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 4; DXE

Catalog Number	SEPC4
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2018
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 in the superior mesenteric vein (smv) using an indigo system separator 4 (sep4).During the procedure, the physician made approximately 4 to 5 passes using the sep4 within an indigo system aspiration catheter 6 (cat6).However, the bulb of the sep4 began to unravel and, therefore, the sep4 was removed.The procedure was completed using a new sep4 with the same cat6.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the sep4 was kinked approximately 63.0 cm, 88.0 cm and 109.5 cm from the proximal end.The stainless steel wrapping wire proximal to the bulb were unraveled starting approximately 180.0 cm from the proximal end of the device.The core wire was fractured proximal to the bulb, approximately 198.5 cm from the proximal end of the device.The distal fractured segment was within the rhv.Minor kinks were present on the distal fractured segment of the delivery wire and the separator bulb was intact.Conclusions: evaluation of the returned sep4 revealed a core wire fracture proximal to the bulb.The sep4 bulb was connected via the wrapping wire to the proximal portion of the fractured delivery wire.This damage was likely a result of the reported repeated manipulation of the sep4 through tough clot burden.If the core wire fractures and the device is retracted, the wrapping wire may start to unravel.The returned condition suggests that retracting the sep4 through the rhv may have contributed to additional unraveling of the wrapping wire.Further evaluation revealed kinks along the length of the device.Based on the return condition and the reported complaint, these kinks were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.

• Brand Name: INDIGO SYSTEM SEPARATOR 4
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8242332
• Report Number: 3005168196-2019-00085
• Device Sequence Number: 1333211
• Product Code: DXE
• UDI-Device Identifier: 00814548017594
• UDI-Public: 00814548017594
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K163618
• 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,Followup
• Report Date (Section B): 12/14/2018
• 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: 04/05/2020
• Device Catalogue Number: SEPC4
• Device Lot Number: C01120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005