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

Catalog Number	SEP8
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the indigo system separator 8 (sep8) bulb was fractured off its core wire approximately 148.0 cm from the proximal end, and the coil wire was unraveled.Conclusions: evaluation of the returned device confirmed that the sep8 bulb had fractured off from its core wire, and the coil wire was unraveled.This type of damage typically occurred due to improper handling during use.If the sep8 is withdrawn forcefully against resistance, damage such as this may occur.Furthermore, prolonged interaction with chronic clot components could cause the core wire to fatigue, making it more prone to malfunction.Sep8 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure treating a pulmonary embolism using an indigo system separator 8 (sep8).During the procedure, the physician used a sep8 with an indigo system aspiration catheter (cat8) for over two hours to successfully remove thrombus.After removing the sep8 in order to de-clog the cat8, the physician noticed that the sep8 bulb had sheared off.Therefore, the physician opened a new sep8 and completed the procedure using the same cat8.After completing the procedure, the physician noticed that the sep8 bulb was lodged into a distal pulmonary branch of the patient's lung.The sep8 bulb was left in the patient since the physician doesn¿t believe that leaving the sep8 in the patient¿s lung would cause any harm.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: 6172126
• Report Number: 3005168196-2016-01830
• Device Sequence Number: 11117417
• Product Code: DXE
• UDI-Device Identifier: 00814548016153
• UDI-Public: 00814548016153
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• 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): 11/19/2016

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: Physician
• Device Expiration Date: 05/16/2019
• Device Catalogue Number: SEP8
• Device Lot Number: F69329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2016
• Initial Report FDA Received Date: 12/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR