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

Model Number	83786
Medical Device Problem Codes	Difficult to Insert (1316); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 10may2022.It was reported that the coil became stuck in the hub of the catheter and detached prematurely near the two-way stopcock.The target lesion was located in the internal iliac artery.A 12mmx20cm interlock-35 coil was selected for use.During the procedure, it was noted that the coil was stuck in the hub of the catheter and detached prematurely near the two-way stopcock.When the coil was recovered, it was noted that it was in a disconnected state inside the catheter.Only the coil was pulled out and the procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that the interlocking arm was detached and there were missing fiber bundles.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the main coil and delivery wire arms were not interlocked.The twist lock of the introducer sheath had been opened.The introducer sheath was kinked.Blood was noticed inside the introducer sheath.The delivery wire was inspected, and no anomalies were noted.The coil was inspected, and it was found kinked and stretched.Microscopic inspection of the delivery wire revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noted.Microscopic inspection of the main coil revealed that the zap tip has a smooth surface.The interlocking arm was detached.Dimensional inspection of the delivery wire and main coil revealed that the components were within specification except the number of fiber bundles, which were only 16 out of 22-32.No other issues were identified during the product analysis.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14574784
• Report Number: 2134265-2022-05926
• Device Sequence Number: 20103104
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• 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): 06/02/2022

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: 02/04/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0025160161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2020
• 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: CATHETER - TODAI 1
• Patient Sex: Unknown