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	12/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The main coil, the delivery wire and the introducer sheath were returned.The main coil and the delivery wire were not interlocked inside the introducer sheath.Blood was noticed inside the introducer sheath.Twist lock was opened.The main coil was kinked and detached at the interlocking arm.Since the device were not interlocking the functional test could not be performed.Under magnification it was possible to observe the main coil detached at the interlocking arm section.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 06feb2023.It was reported that the coil became stuck inside the catheter.The target lesion was located in the mildly tortuous and non-calcified internal iliac artery.A 6mmx20cm interlock-35 coil was selected for use in the aneurysm.During the procedure, it was noted that the device got stuck inside the angiographic catheter at about 10cm from the catheter hub.The coil was removed from the patient's body without problem and the procedure was completed with another of the same device.There was no patient injury.However, device analysis revealed a main coil detached at the interlocking arm section.

• 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: 16448514
• Report Number: 2124215-2023-08918
• Device Sequence Number: 5875868
• Product Code: KRD
• UDI-Device Identifier: 08714729793021
• UDI-Public: 08714729793021
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2023

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: 03/20/2025
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0029075615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ANGIOGRAPHIC CATHETER - IMPRESS 5FR; GUIDEWIRE - RADIFOCUS; INTRODUCER SHEATH - DESTINATION
• Patient Sex: Unknown