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

Model Number	83786
Medical Device Problem Codes	Premature Activation (1484); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that the coil was returned inside a non-bsi catheter (merit catheter).The coil was stuck inside the non-bsi catheter, it was necessary to cut the catheter in order to release the main coil.The interlocking arm of the coil was detached, and the part was not returned.The delivery wire and introducer sheath were not returned for this complaint.The coil was inspected, and it was found kinked and stretched.Microscopic inspection revealed that the zap tip of the main coil has a smooth surface.The interlocking arm was inspected, and the interlocking arm was detached.The zap tip of the pusher wire has a smooth surface and the interlocking arm was inspected, and no damages were noticed.Dimensional inspection of the delivery wire that could be measured were performed and were within specifications.Dimensional inspection of the main coil that could be measured were performed and observed that the outer diameter (od) of the zap tip and primary coil were within specifications.However, the number of distal and proximal fiber bundles were lacking.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that the interlocking detached inside the catheter.The target lesion was located in the internal iliac artery.A total of 3 controllable coils including a 18mmx20cm and 12mm x 20cm interlock were used in the procedure.During the procedure, it was noted that the second coil (18mmx20cm) was stretched and the interlocking arm detached upon delivery, prior to the coil being successfully placed in the patient.Subsequently, part of the coil was still in the radiography catheter, so the physician tried to push the coil many times out of the catheter by means of the coil delivery shaft, a 0.035 guide wire, and manually pushing heparin saline.These attempts failed.Then, a third coil (12mmx20cm) successfully pushed the 18mmx20cm coil out of the angiography catheter and attached to the lesion.However, the head end of the 12mmx20cm coil could not be pushed out smoothly and was prematurely detached in the catheter while trying to deliver.The interlocking arm detached in the process of trying to deliver and the coil was withdrawn with the angiography catheter.The device was completely removed without any intervention and the procedure was completed with a different device.There were no complications reported and the patient is stable.However, device investigation revealed that the interlocking arm was detached and there were 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: 12394964
• Report Number: 2134265-2021-11049
• Device Sequence Number: 17172609
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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: 10/20/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0026218780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 58