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

Model Number	83786
Medical Device Problem Codes	Human-Device Interface Problem (2949); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Only a main coil was returned for this complaint.The coil was found kinked and stretched.The zap tip has a smooth surface.The interlocking arm was detached and it was not returned.Dimensional inspection of the zap tip od, primary coil od and distal fiber bundles were within specifications.There were missing proximal fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 21 jul 2020.It was reported that the coil could not be pulled or pushed.The target lesion area was located in the upper gastrointestinal tract.A 8mm x 20cm interlock-35 embolic was selected for a transjugular intrahepatic portosystemic shunt.During the procedure, the coil was deployed but the position was poor.It was further reported that the device was once deployed but the deployment location can not cure the patient, so adjustments were done twice but it could not be pulled nor pushed.It was tried several times, the coil and the catheter were simply pulled out of the patient's body.Then, it was noted that the interlocking detachable arms were kinked.The procedure was completed with another of the same device.No patient complications reported and patient was stable post procedure.However, device analysis revealed a detached interlocking arm and missing fiber bundles.

• 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: 10362403
• Report Number: 2134265-2020-10379
• Device Sequence Number: 14055642
• Product Code: KRD
• UDI-Device Identifier: 08714729793045
• UDI-Public: 08714729793045
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2020

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: Health Professional
• Device Expiration Date: 12/17/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0024951739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 70