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

Model Number	83779
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The main coil, pusher wire and introducer sheath were returned for this complaint.The main coil and the pusher wire were interlocked within introducer sheath.Introducer sheath was observed, and no damages were noted.The pusher wire was observed, no damages were observed.The main coil was found kinked and severely stretched.No more damages were found in the device.Functional inspection was performed and the pusher wire was advanced through the introducer sheath, but it was not possible to continue advancing it because the coil was stuck, it was necessary to cut the introducer sheath in order to release the main coil.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.Microscopic inspection of the pusher wire was performed and revealed that the proximal end has a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.Dimensional inspection of the pusher wire was performed and the remaining measured dimensions were within specification.Dimensional inspection of the main coil was performed and there were missing fiber bundles due to the 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 03feb2022.It was reported that the coil became stuck in the catheter.The target lesion was located in the mildly tortuous internal iliac artery.A 22mmx60cm 2d interlock coil was selected for use.During the procedure, it was noted that the coil became stuck in the catheter middle part.The coil was pulled out as it is from the patient's body and the procedure was completed with another of the same device.There was no patient injury.However, device analysis revealed missing fiber bundles.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13598232
• Report Number: 2134265-2022-02047
• Device Sequence Number: 5947074
• Product Code: KRD
• UDI-Device Identifier: 08714729845324
• UDI-Public: 08714729845324
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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: 02/07/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026939801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICRO CATHETER - LANTERN
• Patient Sex: Unknown