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

Model Number 83787

Device Problems Premature Activation (1484); Difficult to Advance (2920)

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

Event Date 01/28/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The main coil was returned, and it was observed that it was stretched, kinked and the interlocking arm was detached.No more damages were observed.A part of the original box was returned, and it was observed that the pouch information matches with the complaint information.Under the microscope was observed that the main coil was detached in the coil arm section.The functional test could not be performed due the main coil and the delivery wire were not interlocked.Dimensional inspection of the coil that could be measured were performed and revealed that the outer diameter (od) of the zap tip and primary coil were within specifications.However, the coil arm od could not be measured due the interlocking arm was detached.

Event Description

Reportable based on device analysis completed on 16mar2023.It was reported that the coil was delivered with too much resistance and unscrewed.The target lesion was located in the severely tortuous and moderately calcified left iliac artery of the abdominal aorta.An 8mmx20cm interlock-35 was selected for use.During embolization of the left internal iliac artery, it was noted that the coil was delivered into the direxion catheter with too much resistance.Subsequently, the coil unscrewed after pullback and was then unusable.The procedure was completed with a different device.No complications reported and patient was stable.However, analysis revealed that the main coil detached in the coil arm section.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16702582
• MDR Text Key: 313017649
• Report Number: 2124215-2023-16155
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793052
• UDI-Public: 08714729793052
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0027358174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• 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- DIREXION
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 70 KG