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

Catalog Number	SEP8
Medical Device Problem Codes	Break (1069); Material Separation (1562); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: the platinum and core wires were fractured approximately 149.0 cm from the proximal end of the delivery wire, and the bulb was separated from the delivery wire.Conclusions: evaluation of the returned device confirmed that platinum and core wires were fractured and the sep8 bulb was dislodged from its delivery wire.This type of damage typically occurs due to improper handling during use.If the device was forcefully retracted against resistance, damage such as this may occur.The cat8 mentioned in the complaint was not returned for evaluation.Penumbra devices 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 to treat a deep vein thrombosis (dvt) in the lower left extremity (lle) using an indigo system separator 8 (sep8).During the procedure, while using the sep8 with an indigo system aspiration catheter 8 (cat8), the physician did not mention any resistance; however, the bulb of the sep8 became dislodged from the wire.Therefore, the cat8 and the remainder of the sep8 were removed and a snare device was used to remove the dislodged bulb.The physician then re-inserted the cat8 into the patient¿s body and removed the remaining thrombus.A stent was then placed to treat the iliac narrowing and the procedure was completed.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: 6531982
• Report Number: 3005168196-2017-00636
• Device Sequence Number: 95572
• Product Code: DXE
• UDI-Device Identifier: 00814548016153
• UDI-Public: 00814548016153
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 04/05/2017

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: 04/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 04/28/2017
• 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: 57 YR