MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83786
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil left filaments behind, was pushed to the vessel and secured by few other coils.The target lesion was located in the non tortuous and non calcified left ovarian vein.A 15mm x 20cm interlock coil was selected for treatment.During deployment of the coil, a filament was seen under fluoroscopy trailing behind the pusher wire and then the 5f non boston scientific catheter.When the catheter was pulled back, it was noted that the coil was unraveled and left behind a filament.The physician was able to retrieve the pusher wire but no coil was attached.Consequently, the catheter was flushed but the filament was still stuck to the catheter.The physician then used a 0.035 non boston scientific hydrophilic wire to try to dislodge the coil from the catheter.The coil was in place and pushed to the vessel.The physician decided not to remove the coil since the filament did not extend beyond the ovarian vein into the renal vein.Then, a few other interlock coils were placed proximal to the filament to secure it to the ovarian vein and prevent migration.No further patient complications were reported and the patient was okay post procedure.
Additional Manufacturer Narrative
The complaint device was not returned by the customer; nevertheless, physician has provided pictures of the device.The picture attached is an x-ray, it can be observed that the coil was unraveled and stretched within patient body.
Event or Problem Description
It was reported that the coil left filaments behind, was pushed to the vessel and secured by few other coils.The target lesion was located in the non tortuous and non calcified left ovarian vein.A 15mm x 20cm interlock coil was selected for treatment.During deployment of the coil, a filament was seen under fluoroscopy trailing behind the pusher wire and then the 5f non boston scientific catheter.When the catheter was pulled back, it was noted that the coil was unraveled and left behind a filament.The physician was able to retrieve the pusher wire but no coil was attached.Consequently, the catheter was flushed but the filament was still stuck to the catheter.The physician then used a 0.035 non boston scientific hydrophilic wire to try to dislodge the coil from the catheter.The coil was in place and pushed to the vessel.The physician decided not to remove the coil since the filament did not extend beyond the ovarian vein into the renal vein.Then, a few other interlock coils were placed proximal to the filament to secure it to the ovarian vein and prevent migration.No further patient complications were reported and the patient was okay post procedure.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11788463
• Report Number: 2134265-2021-05134
• Device Sequence Number: 3949072
• Product Code: KRD
• UDI-Device Identifier: 08714729793120
• UDI-Public: 08714729793120
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 03/11/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0025343254
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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