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

Model Number	83786
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: a delivery wire, coil and introducer sheath were returned for this complaint.The coil and delivery wire arms were interlocked.The twist lock of the introducer sheath had been opened.The delivery wire was inspected and no anomalies were noted.The coil was inspected and it was found kinked and stretched.Functional inspection was performed and the delivery wire was advanced through the introducer sheath, but it was not possible to continue advancing it because the coil was stuck, due the stretched condition.The coil was pulled out backwards in order to release the main coil.Microscopic inspection of the delivery wire was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected and it was detached.Dimensional inspection of the delivery wire was performed and the measured dimensions were within specification.Dimensional inspection of the main coil was performed and there were missing fiber bundles on the main coil due to coil condition.The remaining measured dimensions were within specification.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 22feb2021.It was reported that the coil was stuck in the catheter.The target lesion was located in the moderately tortuous subclavian artery.A 12mmx20cm 2d interlock-35 coil was selected for use.During the procedure, it was noted that the coil got stuck in the distal part of the catheter.The device was removed together with the catheter and the procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed main coil interlocking arm detachment and fiber loss.

• 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: 11484845
• Report Number: 2134265-2021-03114
• Device Sequence Number: 3412347
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/15/2021

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: 09/11/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0024418045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 5FR SELECON