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

Model Number	83779
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that the coil became unraveled and prematurely detached within the y-connector.An 8mmx20cm interlock coil was selected for use.During the procedure, when the coil was withdrawn, it was noted the coil was unraveled and had prematurely detached within the y connector.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the interlocking arm of the main coil was detached from the coil.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.Only the main coil was returned.The main coil was stretched, kinked and its interlocking arm was detached.Microscopic inspection was performed, and it was noted that the interlocking arm of the main coil was detached.The functional inspection could not be performed as only the main coil was returned.Dimensional inspection of the main coil zap tip outer diameter (od) and primary coil od was performed and were within specifications.Coil arm od could not be measured due to the detached interlocking arm.No other issues were identified during the product analysis.

• Brand Name: INTERLOCK
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16004528
• Report Number: 2124215-2022-53180
• Device Sequence Number: 15138019
• Product Code: KRD
• UDI-Device Identifier: 08714729765011
• UDI-Public: 08714729765011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132578
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2022

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: 06/11/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0029748237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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