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

Model Number	83786
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil protruded from the catheter tip and interlocking buckle fell off.The moderately stenosed target lesion area was located in moderately tortuous and moderately calcified gastric vein.A 8mmx20cm interlock-35 embolic was selected for use in a gastic coronary vein emobolization.Three interlock coils were used for the procedure.The second coil was unable to advance and stuck, and the protective sheath could not be retrieved despite many attempts but the system was replaced.The device was pulled out wih the coil protruding out of the catheter's tip upon removal from the patient.The procedure was completed with another of the same device.However, post procedure, it was noted that the reported damaged coil was stretched and the interlocking buckle fell off.There were no patient complications reported, and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by the manufacturer: the device was returned for analysis.Visual inspection revealed, that the main coil, the delivery wire and introducer sheath were returned for this complaint.The coil was found inside of an unknown microcatheter.Also was found kinked and stretched.The delivery wire was inside the introducer sheath.Microscopic inspection, of the delivery wire revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no damages were found.For the main coil, the zap tip has a smooth surface.The main coil was stretched and kinked.The interlocking arm was detached.Dimensional inspection of the main coil revealed that the overall dimension of the zap tip and the primary coil matches with the specification while the number of the distal and proximal fiber bundles did not match the specifications.For the delivery wire, the overall dimension of the weld and wire arm as well as the wire zap are within the specifications.
Event or Problem Description
It was reported that the coil protruded from the catheter tip and interlocking buckle fell off.The moderately stenosed target lesion area was located in moderately tortuous and moderately calcified gastric veins.A 8mm x 20cm.035 interlock embolics was selected for use in gastric coronary vein embolization.During the procedure, it was noted that a total of three coils were used, however, when this device was advanced it could not be advance to one third of the way as it got stuck and at this time, the protective sheath could not be retrieved.The device was simply pulled out wih the coil protruding out of the catheter's tip upon removal from the patient.The system was replaced and the procedure was completed with another of the same device.Subsequently after the procedure, the coil was found stretched, and the interlocking buckle fell off.There were no patient complications reported and the patient is stable.It was further reported that there were no fiber bundles left inside the patient's body.

• 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: 11485125
• Report Number: 2134265-2021-02718
• Device Sequence Number: 3412349
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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: 05/06/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0025493567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 50