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	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A delivery wire, a main coil, and introducer sheath were returned for this complaint.The coil and delivery wire arms were inside the introducer sheath.Residues of blood was noted inside the introducer sheath.The introducer sheath was inspected and no anomalies were noted, the twist lock had been opened.The coil was kinked and stretched.The interlocking arm of the coil was detached.The delivery wire was advanced through the introducer sheath, but it was not possible to continue advancing it due to the main coil was stuck; it was necessary to cut the sheath in order to release the main coil.After release the coil was noted kinked, stretched and without interlocking arm.Microscopic inspection of the delivery wire was performed and observed that the proximal end has a smooth surface.No damages were found within the interlocking arm.Microscopic inspection of the main coil was performed and observed that the zap tip has a smooth surface.The interlocking arm was detached.Dimensional inspection of the delivery wire that could be measured was performed and were within specifications.Microscopic inspection of the main coil revealed that the no.Of proximal fiber bundles, outer diameter (od) of the zap tip and primary coil were within specification, however there were lacking no.Of distal fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 21jan2021.It was reported that the coil stuck in the catheter.The target lesion was located in the splenic artery.A 15mm x 20cm interlock-35 was selected for use.The coil became stuck in the distal part of the catheter and was removed with the catheter.A new coil was selected, however, it failed to detach.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that the interlocking arm of the coil was detached and fiber bundles were incomplete.

• 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: 11280561
• Report Number: 2134265-2021-01182
• Device Sequence Number: 11435169
• Product Code: KRD
• UDI-Device Identifier: 08714729793120
• UDI-Public: 08714729793120
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

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: 07/03/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0024059210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1