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	07/29/2020
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the iliac and femoral veins using an indigo system separator 8 (sep8) and an indigo system aspiration catheter 8 (cat8).During the procedure, the tip of the sep8 bulb broke off and lodged in the clot while using the sep8 with the cat8.Therefore, the sep8 was removed and no longer used.Next, the physician made separate attempts to remove the sep8 tip using a snare device and a balloon device.However, attempts to retrieve the sep8 tip were unsuccessful and the physician decided to leave it inside the patient.The procedure was completed using the same cat8.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the sep8 was fractured approximately 149.5 cm from its proximal end.Conclusions: evaluation of the returned sep8 confirmed that the atraumatic tip was fractured distal to the bulb.If the sep8 is repeatedly manipulated through tough clot burden the tip can become weakened.Subsequent manipulation within clot burden may cause the tip to fracture.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.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10440528
• Report Number: 3005168196-2020-01267
• Device Sequence Number: 2452738
• Product Code: DXE
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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): 07/29/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2023
• Device Model Number: SEP8-A
• Device Catalogue Number: SEP8
• Device Lot Number: F96126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 08/22/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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: Required Intervention
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005