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

Model Number	83779
Medical Device Problem Codes	Premature Activation (1484); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.The coil, pusher wire, and introducer sheath were returned for this complaint.The coil was stuck inside the introducer sheath.The pusher wire was returned outside the introducer sheath.The main coil was found kinked and severely stretched.No more damage was found.Microscopic inspection was performed on the coil.The zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies were noted.Microscopic inspection was performed on the pusher wire.The proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies were noted.Dimensional inspection on the main coil revealed that the zap tip od (max) outer diameter, primary coil od were within specification.However, the number of fiber bundles were below specification indicating fiber loss due to coil condition.Dimensional inspection on the pusher wire revealed that the distal solder joint o.D, mid solder joint o.D., distal tfe o.D.And proximal tfe o.D.Were within specification.
Event or Problem Description
Reportable based on device analysis completed on 28oct2021.It was reported that the spring coil could not be advance and prematurely deployed.The target lesion was located in the celiac axis.A 14mm x 30cm interlock coil was selected for use.During the procedure, multiple coils were used, three 10mmx30cm and a 14mmx30cm accordingly.However, when the 14mmx30cm was deployed, it was noted that the spring coil could not be advanced and prematurely released in the microcatheter.The device was simply pulled out from the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient was good post procedure.However, device analysis revealed that fiber bundles were missing.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12788942
• Report Number: 2134265-2021-13660
• Device Sequence Number: 12032528
• Product Code: KRD
• UDI-Device Identifier: 08714729765073
• UDI-Public: 08714729765073
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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: 08/02/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024360353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2019
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 70 KG