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

Model Number	83786
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Main coil, delivery wire and introducer sheath return for this complaint.Main coil and delivery wire returned separate, twist lock was open.Main coil was found severely stretched and kinked.Delivery wire was inspected and no damages were found.Introducer sheath was inspected and no damages were found.Microscopic inspection of the pusher wire revealed that the proximal end has a smooth surface.The interlocking arm was inspected and no damages were found.The interlocking arm was detached and the part was not returned.Dimensional inspection revealed that the overall dimension (od) of the weld, wire arm and wire zap tip matches with specification.For the main coil, the number of proximal fiber bundles, zap tip od and primary coil od were within the specification.However, the number of distal fiber bundles did not match with specification, thus, fiber loss due to stretched condition was noted.
Event or Problem Description
Reportable based on device analysis completed on 15dec2021.It was reported that the device stretched and failed to deploy.The target lesion was located in the esophagogastric fundus vein.A 18mmx40cm interlock-35 was selected for use.During the procedure, it was noted that resistance was encountered upon repeatedly delivering the device, and so the device was simply pulled out.However, it was found that the coil was unwound and failed to deploy and got stretched.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.However, device investigations revealed loss of fibers and the interlocking arm detached.

• 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: 13196829
• Report Number: 2134265-2021-16411
• Device Sequence Number: 4389883
• Product Code: KRD
• UDI-Device Identifier: 08714729795414
• UDI-Public: 08714729795414
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2022

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: 05/26/2024
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0027391359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 73 KG