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

Model Number	83779
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The main coil, pusher wire and introducer sheath were returned for this complaint.The main coil and the pusher wire were not interlocked within introducer sheath.Introducer sheath was observed, and no damages were noted.Twist lock was opened.It is important to mention that it was necessary to cut the introducer sheath to release the main coil and the mid soldier joint section of the introducer sheath.Blood was noticed inside the introducer sheath.The pusher wire was kinked and detached at mid soldier joint section.The main coil was found kinked and stretched.Dimensional inspection of the pusher wire and main coil revealed the components were within specification.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 28sep2022.It was reported that the coil could not be pushed out of the catheter.The target lesion was located in the splenic artery aneurysm.A 14mm x 50cm interlock was selected for use.During the procedure, it was reported that the coil could not be pushed out of the catheter.The entire catheter was removed and the procedure was completed with another of same device.No complications were reported and patient was stable post procedure.However, device analysis revealed that the pusher wire was detached at mid soldier joint section.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15663931
• Report Number: 2124215-2022-40910
• Device Sequence Number: 6471036
• Product Code: KRD
• UDI-Device Identifier: 08714729845294
• UDI-Public: 08714729845294
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2022

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: 06/07/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027629423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• 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 Age: 48 YR
• Patient Sex: Female
• Patient Weight: 67 KG