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

Catalog Number	SEPD
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00420.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in an arteriovenous (av) graft in the left arm using an indigo system separator d (sepd) and an indigo system catd aspiration catheter (catd).It should be noted that according to the physician, the graft had been clotted for two weeks or more.During the procedure, the physician experienced resistance while advancing the sepd and an indigo system catd aspiration catheter (catd) in tandem.However, it was also reported that the resistance felt during advancement was nothing more than the physician normally expects in these procedures.After making several passes in the target vessel with the tandem devices, the penumbra sales representative was looking at the fluoroscopic visualization and realized that the distal tip of the sepd wire had broken off and had become embedded in the thrombus within the patient¿s arm.The devices were then removed from the patient and the mechanical thrombectomy procedure was ended.Unrelated to the broken piece of wire, the physician decided to transfer the patient to the operating room (or) for an open thrombectomy procedure to remove the heavy clot burden.During the open thrombectomy procedure the physician removed the clot and the broken piece of wire from the patient and the procedure was ended.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the information below was not reported on the initial mfr report and is being included on this follow-up#01 mfr report: outcomes attributed to adverse event.Results: the core wire and wrapping wire were fractured distal to the bulb approximately 90.0 cm from the proximal end.Clotted blood was present on the distal tip.No additional damage was present on the device.Conclusions: evaluation of the returned sepd confirmed a device with a fractured distal tip.If the sepd is manipulated repeatedly through tough clot burden, as reported in the complaint, damage such as a core wire fracture may occur.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.This report is associated with mfr report number: 3005168196-2019-00420.

• Brand Name: INDIGO SYSTEM SEPARATOR D
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8397529
• Report Number: 3005168196-2019-00419
• Device Sequence Number: 240500
• Product Code: DXE
• UDI-Device Identifier: 00814548017600
• UDI-Public: 00814548017600
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 02/04/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2021
• Device Catalogue Number: SEPD
• Device Lot Number: F85398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005