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

Model Number	83786
Medical Device Problem Codes	Premature Activation (1484); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A delivery wire, main coil and introducer sheath were returned for this complaint.All parts were returned inside a non-boston scientific catheter.The introducer sheath was visually inspected, and the twist lock had been opened.The coil was inspected, and it was found kinked and stretched.The delivery wire was in good condition.No more damages were found.Microscopic inspection of the delivery wire was performed and revealed that the zap tip had a smooth surface.The interlocking arm was inspected, and no damage was found.Microscopic inspection of the main coil was performed and showed that the zap tip had a smooth surface.The interlocking arm was inspected, and it was found detached.The detached part was not returned.Dimensional inspection of the delivery wire was performed and the measured dimensions were within specification.Dimensional inspection of the main coil was performed and there were missing fiber bundles on the main coil, due to coil stretching condition.The remaining measured dimensions were within specification.No other issues were identified during the product analysis.The use of a non-recommended catheter during the delivery may have affected the advancement of the device, affecting performance and intended purpose.
Event or Problem Description
Reportable based on device analysis completed on 20apr2021.It was reported that the coil detached prematurely inside the catheter.The target lesion was located in the ovarian vein.A 6mmx20cm 2d interlock-35 coil was selected for use.During the procedure, the coil did not detach even when the physician used a slight twisting motion to help detach the coil outside the catheter.The physician retrieved the coil and it was found that the coil detached prematurely within the 5f catheter.The coil was removed from inside of the 5f catheter and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.However, device analysis revealed 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: 11808999
• Report Number: 2134265-2021-05573
• Device Sequence Number: 3634887
• Product Code: KRD
• UDI-Device Identifier: 08714729793021
• UDI-Public: 08714729793021
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 07/09/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0025690753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1