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

Model Number	83786
Medical Device Problem Codes	Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was difficult to remove and penetrated the non-boston scientific balloon catheter.The stenosed target lesion was located in the severely tortuous left esophageal vein.A 6mmx10cm interlock-35 coil was selected for use.During the procedure, after the coil was placed, the physician encountered resistance when retrieving the delivery wire.The delivery wire penetrated the balloon portion of the non-boston scientific balloon catheter, but did not penetrate the lesion.The interlock-35 delivery wire was removed together with the non-boston scientific balloon catheter.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that the device was difficult to remove and penetrated the non-boston scientific balloon catheter.The stenosed target lesion was located in the severely tortuous left esophageal vein.A 6mmx10cm interlock-35 coil was selected for use.During the procedure, after the coil was placed, the physician encountered resistance when retrieving the delivery wire.The delivery wire penetrated the balloon portion of the non-boston scientific balloon catheter, but did not penetrate the lesion.The interlock-35 delivery wire was removed together with the non-boston scientific balloon catheter.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.Only the pusher wire returned for the analysis, and no damages or issues were observed.The functional test could not be performed due only the pusher wire was returned.Dimensional inspection on delivery wire revealed that the weld od outer diameter (max), wire arm od (max), and wire od (max) were within specification.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17199150
• Report Number: 2124215-2023-29800
• Device Sequence Number: 12428898
• Product Code: KRD
• UDI-Device Identifier: 08714729793007
• UDI-Public: 08714729793007
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 0030336245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER - SELECON.; BALLOON CATHETER - SELECON.
• Patient Sex: Unknown