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

Model Number	83786
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.The introducer sheath, the main coil and the delivery wire were inspected.No damages were found.The twist lock was opened.Blood was observed inside the introducer sheath.The delivery wire and the main coil were not interlocked.The main coil was stretched and the interlocking arm was detached.Microscope inspection revealed that the interlocking arm of the main coil was detached.
Event or Problem Description
Reportable based on device analysis completed on 27jul2022.It was reported that the device could not be pushed.Vascular access was obtained via the internal iliac artery.A 15mmx40cm interlock-35 was selected for use.During the procedure, it was noted that the device was inserted and extended about 10cm from a non-boston scientific catheter tip.The interlock was retracted inside the catheter for repositioning and was advanced again; however, it could not be pushed, so it was removed outside the body.As per physician's comment, it seemed that thrombosis occurred in the angiographic catheter and device got stuck when interlock that came in contact with the blood again was retracted inside the angiographic catheter.Only the coil was removed and the procedure was completed with another of the same device.There were no patient complications reported.However, device investigations revealed that the interlocking arm was detached.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15254834
• Report Number: 2134265-2022-08450
• Device Sequence Number: 6635987
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: 08714729793144
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2022

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: 03/09/2025
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0029021408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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