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

Model Number	83786
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.Main coil, introducer sheath and delivery wire were returned for this complaint.Coil and delivery wire were not interlocked within introducer sheath.The main coil was inside of the introducer sheath.The delivery wire was out of the introducer sheath.The introducer sheath was inspected, and no damages were found, an important amount of blood was noticed.The coil was inspected, and it was found kinked and stretched.Twist lock have been opened.No more damages were found.Microscopic inspection was performed on main coil.The zap tip has a smooth surface.The interlocking arm was inspected, and it was found detached (part did not return).Microscopic inspection was performed on delivery wire.The distal end has a smooth surface.The interlocking arm was inspected, and no damages were found.Dimensional inspection on main coil revealed that the number of distal fiber bundles, number of proximal fiber bundles, zap tip od (outer diameter) and primary coil od were within specification.Dimensional inspection on delivery wire revealed that the weld od (max), wire arm od and wire zap tip (max) were within specification.
Event or Problem Description
Reportable based on device analysis completed on 30sep2021.It was reported that the device could not be removed in the protective sheath.A 6mm x 20cm interlock -35 coil was selected for use.During the procedure, it was noted that the coil could not be removed in the protective sheath.The device was simply pulled out from the patient's body.The procedure completed with another of the same device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that the interlocking arm was 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
• MDR Report Key: 12667916
• Report Number: 2134265-2021-12468
• Device Sequence Number: 17218063
• Product Code: KRD
• UDI-Device Identifier: 08714729793021
• UDI-Public: 08714729793021
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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: 11/24/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0026415985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR