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

Model Number	83786
Medical Device Problem Codes	Break (1069); Separation Failure (2547); Poor Visibility (4072)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil broke in half and vessel spasm occurred.A 6mm x 20cm interlock-35 was selected for use in the varicoceles.During the procedure, the coil and catheter were flushed.The plastic introducer sheath was seated in the hub of the non-boston scientific catheter.The plastic introducer could not be advanced any further, and that the tip was in the lumen of the catheter, beyond the hub.The y adapter was gently tightened to grip the plastic sheath and the twist lock was untwisted.The coil wire and the catheter were advanced until the tip was positioned correctly, and the coil was deployed in place.The marker to identify where the interlocking arms were was not visible.The physician thought that he had finished deploying the coil, and that the interlocking arms had detached.The wire was retrieved, and the physician began preparing for the third coil.However, upon turning back to the patient, it was noted that the last coil was not in place and had not been deployed; instead, the coil had been dragged back by the wire, into the catheter and was half in the hub of the catheter and half broken on the scrub table, near the wire.The broken half of the coil could not be removed from the hub, so the hub was cut off.The vessels had gone into spasm, so it took 45mins to re-establish positioning in the varicoceles with a non-boston scientific catheter.The procedure was completed with a non-boston scientific device.No patient complications were reported.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15987188
• Report Number: 2124215-2022-52654
• Device Sequence Number: 5950214
• Product Code: KRD
• UDI-Device Identifier: 08714729793021
• UDI-Public: 08714729793021
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2022

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: 10/12/2025
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0030336250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown