MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83779
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil separated from the middle part and remained inside patient.The target lesion was located in the bronchial artery.A 8cmx3mm interlock was selected for use.During the procedure, it as noted that the coil became stuck on the tip part of a non-bsc catheter and was removed.However, the coil separated at the middle part and was left inside patient from bronchial artery to aorta.The proximal side was removed protruding from the catheter's tip.A 2mmx4cm interlock was then used and advanced through the catheter.The 2mmx4cm interlock prematurely deployed within the catheter and possibly tore within the catheter during removal.There was no resistance upon retrieving the catheter and the coil and no possibility of adhesion of thrombus.No complications reported and the patient is stable.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9782170
• Report Number: 2134265-2020-02509
• Device Sequence Number: 10888649
• Product Code: KRD
• UDI-Device Identifier: 08714729764939
• UDI-Public: 08714729764939
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

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: 06/17/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024130624
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER- BREAKTHROUGH 2 MARKER; COIL- 2MM X 4CM INTERLOCK
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR