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

Model Number 83786

Device Problems Difficult to Insert (1316); Premature Activation (1484)

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

Event Date 04/08/2022

Event Type  malfunction  

Event 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.

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
• 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: 14574784
• MDR Text Key: 293274293
• Report Number: 2134265-2022-05926
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• 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 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
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2020
• 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