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	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that the delivery wire, main coil and introducer sheath were returned for this complaint.The coil and delivery wire arms were not interlocked, the delivery wire was inside the introducer sheath.The introducer sheath was inspected and no anomalies were noted, the twist lock had been opened.The main coil was found kinked and stretched.The coil interlocking arm was detached.For functional inspection, the delivery wire was advanced through the introducer sheath no resistance was noticed.Microscopic inspection revealed that the proximal end of the delivery wire has a smooth surface and the interlocking arm was found in good condition.The zap tip of the main coil has a smooth surface.Dimensional inspection of the delivery wire revealed that the weld overall dimension (od), wire arm od and wire zap tip (max) matches with specification.Also, for the main coil, the zap tip (od), the primary coil (od), and the number of distal and proximal fiber bundles are within specification.
Event or Problem Description
Reportable based on device analysis completed on 04feb2021.It was reported that the coil became stuck.The target lesion area was located in the internal illiac artery.A 2d 12mm x 20cm interlock-35 embolic was selected for use in a pelvic congestion procedure.During the procedure, the coil was unpacked and flushed well.The coil was introduced into the catheter.However, it was stuck at the distal part of the catheter, at the connection part.The coil was pulled, and the procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed a detached interlocking arm.

• 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: 11343149
• Report Number: 2134265-2021-01452
• Device Sequence Number: 4997226
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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: 07/10/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0024091178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 70