MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 5; DXE

Catalog Number	SEP5-A
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2016
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 popliteal artery using an indigo system separator 5 (sep5).During the procedure, the physician advanced the sep5 through an indigo system aspiration catheter 5 (cat5) and started to remove thrombus.After 5-10 seconds of pushing and pulling through the cat5, the sep5 became stretched at the hub and was removed.Although the sep5 was stretched, there was no issue reported with the cat5 device.However, the physician decided to continue the procedure with another manufacturer's aspiration devices.It was later reported that the procedure was not successful and the patient's leg was still thrombosed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the indigo system separator 5 (sep5) was stretched and the bulb was fractured approximately 174.0 cm from the proximal end of the delivery wire.Conclusions: evaluation of the returned device revealed that the sep5 was stretched and the bulb was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted and the force used exceeds product specification, damage such as this may occur.Sep5s are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM SEPARATOR 5
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5458586
• Report Number: 3005168196-2016-00231
• Device Sequence Number: 16236923
• Product Code: DXE
• UDI-Device Identifier: 00814548016108
• UDI-Public: 00814548016108
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121917
• 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): 01/26/2016

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: Physician
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: SEP5-A
• Device Lot Number: F46427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2016
• Supplement Report FDA Received Date: 04/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1