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

Model Number 83786

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device evaluated by mfr: the device was returned for evaluation.The main coil and the introducer sheath were returned for this complaint.Visual inspection revealed that the main coil was kinked and stretched.The introducer sheath was kinked.Twist lock was opened.Microscopic inspection revealed that the zap tip has a smooth surface.The interlocking arm was detached.Dimensional inspection of the main coil revealed that the components were within specification except the number of distal fiber bundles, which were only 14 out of 17 and the number of proximal fiber bundles, which were only 19 out of 37-44.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 12may2022.It was reported that the coil was stuck in the catheter hub part.The target lesion was located in the internal iliac artery.A 12mmx40cm 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 could not be pushed forward.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.

• Brand Name: INTERLOCK-35
• Type of Device: 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: 14574852
• MDR Text Key: 293174066
• Report Number: 2134265-2022-06004
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: 08714729792970
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0027399500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CATHETER - TODAI 1