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

Model Number	83779
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device fracture occurred.The stenosed target lesion was located in the splenic artery.A 20mm x 50cm interlock was selected for use.During preparation, after using a microcatheter, the coil was unpacked in a aseptic way, but when taking the device out, there was no coil in the delivery system, the coil had fractured inside the internal package.The procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.
Additional Manufacturer Narrative
E1.Initial reporter address 1:(b)(6).
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).Only the main coil and the pusher wire were returned.It was observed that the pusher wire was kinked and detached at the middle section.The pouch was returned, and it was observed that the pouch information matches with the complaint information.The functional could not be performed due the main coil and the pusher wire are not interlocking.The dimensional inspection revealed that the outer diameter (od) at coil arm, zap tip and primary coil were found to be within specification.
Event or Problem Description
It was reported that a device fracture occurred.The stenosed target lesion was located in the splenic artery.A 20mm x 50cm interlock was selected for use.During preparation, after using a microcatheter, the coil was unpacked in a aseptic way, but when taking the device out, there was no coil in the delivery system, the coil had fractured inside the internal package.The procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18087932
• Report Number: 2124215-2023-60576
• Device Sequence Number: 12695208
• Product Code: KRD
• UDI-Device Identifier: 08714729845317
• UDI-Public: 08714729845317
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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: 12/25/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030920849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 68 KG