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

Model Number	83779
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the pusher wire, introducer sheath and main coil were returned for analysis.The main coil and pusher wire were interlocked within introducer sheath.Pusher wire was kinked.The main coil was noticed stuck, after being released it was observed kinked and severely stretched.The introducer sheath was inspected, and no damages were found.Functional inspection: the main coil was stuck within introducer sheath it was necessary to cut the introducer sheath in order to release the main coil.Microscopic inspection: pusher wire.The proximal end has a smooth surface.The interlocking arm was inspected, no anomalies were noticed.For the main coil, the zap tip has a smooth surface and the interlocking arm was inspected, no damages found.Dimensional inspection revealed that the overall dimension (od) of the pusher wire, distal solder joint, mid solder joint, distal tfe and proximal tfe were within specifications.For the main coil, the zap tip (od), and primary coil (od) matches with specifications.However, the number of fiber bundles did not match with the specification.
Event or Problem Description
Reportable based on device investigations completed on 28dec2021.It was reported that the device was kinked.The target lesion was located in the splenic artery.A 22mm x 60cm pe-f idc interlock embolics was selected for use.During the procedure, it was noted that after hydrating the interlock with heparin, it was tried delivered through the microcatheter, however, the device was difficult to deliver.After multiple attempts, the push rod of the device and the outer plastic catheter were kinked and deformed.The device was simply pulled out and the procedure was completed with a different device.There were no complications reported and the patient is stable.However, device analysis revealed that there were missing fiber bundles.

• 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13310873
• Report Number: 2134265-2021-16758
• Device Sequence Number: 3346500
• Product Code: KRD
• UDI-Device Identifier: 08714729845324
• UDI-Public: 08714729845324
• 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): 01/20/2022

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: 03/13/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027132717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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 Age: 65 YR
• Patient Sex: Unknown
• Patient Weight: 67 KG