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

Catalog Number	SEP8
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 numbers: 3005168196-2016-01632; 3005168196-2016-01634.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an ilio-femoral deep vein thrombosis (dvt) using indigo system separators 8 (sep8) and indigo system aspiration catheter 8 (cat8).During the procedure, while in use with the cat8, a sep8 bulb broke off after being used during multiple passes.The physician noticed that the sep8 bulb broke off within the cat8 under fluoroscopy and therefore the sep8 was removed.The physician was able to retrieve the broken sep8 bulb by removing the cat8.Upon inspection of the cat8 after removal, the physician noticed the cat8 tip was kinked and stretched due to extensive clot burden.The physician then decided to use a new cat8 with a new sep8.However, the new sep8 bulb broke off while being used to clear the tip of the cat8 as well.The physician noticed the broken sep8 bulb under fluoroscopy therefore the sep8 was removed and the physician then removed the cat8 in order to remove the broken sep8 bulb within it.The physician then re-inserted the same cat8 into the patient¿s body and completed the procedure using a new sep8.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6109931
• Report Number: 3005168196-2016-01633
• Device Sequence Number: 672650
• Product Code: DXE
• UDI-Device Identifier: 00814548016153
• UDI-Public: 00814548016153
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2016

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: 01/06/2019
• Device Catalogue Number: SEP8
• Device Lot Number: F67241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2016
• Initial Report FDA Received Date: 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR