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); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The pusher wire, the main coil and the introducer sheath were returned for this complaint.The coil and pusher wire arms were not interlocked inside the introducer sheath, and blood was noticed.The twist lock of the introducer sheath had been opened.The pusher wire was inspected, and it was kinked.The main coil was found kinked/bent and stretched.No more damages were found in the device.Microscopic inspection of the pusher wire revealed that the proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies were noted.Microscopic inspection of the main coil revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies were noted.Dimensional inspection of the pusher wire and main coil revealed the components were within specification except for the number of fiber bundles, which were only 19 out of 25.The fiber loss was due to the stretched coil condition.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 21apr2022.It was reported that the coil could not be delivered smoothly, detached on its own and was stretched.The target lesion was located in the left gastric artery.A 3mmx6cm interlock coil was selected for use.During the procedure, the micro-catheter was advanced to the bleeding site, a y-valve was connected and an interlock coil was advanced, but it could not be delivered smoothly.After multiple delivery, the coil detached on its own and was stretched.The device was simply pulled out from the patient's body and the procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that there were missing fiber bundles.

• 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: 14435275
• Report Number: 2134265-2022-05167
• Device Sequence Number: 5898039
• Product Code: KRD
• UDI-Device Identifier: 08714729764939
• UDI-Public: 08714729764939
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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: 04/20/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027358171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 70 KG