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

Model Number	83786
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.A delivery wire and main coil were returned for this complaint.The introducer sheath did not return.The coil and delivery wire arms were not interlocked.The twist lock of the introducer sheath had been opened.The delivery wire was inspected, and the interlocking arm was noticed bent.The coil was inspected, and it was found kinked and stretched.Media inspection was performed.Physician has provided pictures of the device.As per pictures provided, it can be observed that the main coil is semi inside of a catheter, the part of the coil that can be seen is kinked and stretched.Also, another picture shows the hoop and the coil completely outside of catheter, it was observed kinked and stretched as well.The box of the product was noticed in good condition per picture provided.Microscopic inspection on delivery wire revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and it was noticed bent.Microscopic inspection on main coil revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and it was detached.Dimensional inspection on the delivery wire revealed that the weld od (max) outer diameter, wire arm od and wire zap tip (max) were within specification.No.Of distal fiber bundles, no.Of proximal fiber bundles, zap tip od and primary coil od were within specification.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that the device was stuck in the catheter.A 12mm x 20cm interlock -35 coil was selected for use.During the procedure, when trying to pass the device through the catheter, it was noted that the coil got stuck inside the catheter.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.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: 12716157
• Report Number: 2134265-2021-12659
• Device Sequence Number: 14628719
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 10/28/2021

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: 01/05/2024
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0026584511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 65