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

Model Number	83779
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the complaint device was received for product analysis.Pusher wire, introducer sheath and main coil were returned for this complaint.The main coil and pusher wire were not interlocked within introducer sheath, all parts returned separated.The pusher wire was inspected, and it was kinked.The main coil was found kinked and stretched.The introducer sheath was inspected, and no damages were found.No more damages were found.Microscopic inspection of the pusher wire was performed and revealed that the proximal end has a smooth surface.The interlocking arm was inspected, no anomalies were noticed.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.The interlocking arm was detached.Dimensional inspection of the pusher wire was performed and the measured dimensions were within specification.Dimensional inspection of the main coil was performed and the 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 13dec2021.It was reported that the coil became stuck inside the catheter middle part.A 22mmx60cm 2d interlock coil was selected for use.During the procedure, it was noted that the coil became stuck inside the catheter middle part.The coil was pulled out 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 that the interlocking arm of the main coil was detached.
Event or Problem Description
Reportable based on device analysis completed on 13dec2021.It was reported that the coil became stuck inside the catheter middle part.A 22mmx60cm 2d interlock coil was selected for use.During the procedure, it was noted that the coil became stuck inside the catheter middle part.The coil was pulled out 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 that the interlocking arm of the main coil was detached.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.Pusher wire, introducer sheath and main coil were returned for this complaint.The main coil and pusher wire were not interlocked within introducer sheath, all parts returned separated.The pusher wire was inspected, and it was kinked.The main coil was found kinked and stretched.The introducer sheath was inspected, and no damages were found.No more damages were found.Microscopic inspection of the pusher wire was performed and revealed that the proximal end has a smooth surface.The interlocking arm was inspected, no anomalies were noticed.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.The interlocking arm was detached.Dimensional inspection of the pusher wire was performed and the measured dimensions were within specification.Dimensional inspection of the main coil was performed and the measured dimensions were within specification.No other issues were identified during the product analysis.

• 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: 13172797
• Report Number: 2134265-2021-16200
• Device Sequence Number: 17299228
• 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,Followup
• Report Date (Section B): 01/27/2022

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: 07/13/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027833396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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
• Patient Sex: Unknown