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

Model Number	83786
Medical Device Problem Code	Separation Failure (2547)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 21feb2022.It was reported that the coil could not be deployed.A 8mm x 20cm interlock coil was selected for use.During the procedure, it was noted that the coil could not be deployed normally.The procedure was completed with a different device.There were no patient complications reported and the patient was stable.However, device analysis revealed that there were missing fiber bundles.
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.The main coil, the delivery wire and introducer sheath were returned for this complaint.The main coil and delivery wire were interlocked within the introducer sheath.The delivery wire and introducer sheath were inspected, and no damages were observed.The main coil was found kinked and stretched.The delivery wire was advanced through the introducer sheath, resistance was noticed, it was necessary to pull it backwards to release the main coil.The zap tip has a smooth surface.The interlocking arm was inspected, and no damages were found.The dimensional inspection revealed that the outer diameter (od) at the zap tip and primary coil were found to be within specification.Also, proximal fiber bundles were found to be within specification, however, distal fiber bundles were not within the specifications.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13764688
• Report Number: 2134265-2022-02662
• Device Sequence Number: 4993362
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2022

1 Device 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: 03/29/2024
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0027058814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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