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

Model Number 83787

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.A visual inspection was performed and it was observed that only the main coil was returned.It was observed that the main coil was bent and stretched at the coil arm and primary coil section.Also, the arm coil was detached.The functional inspection of the device could not be performed due to only the main coil was returned.Dimensional inspection of the main coil revealed the components were within specifications.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 29feb2024.It was reported that the coil was stuck in the end catheter and could not be retracted.The patient with aneurysmal dilatation of the thoracic aorta underwent thoracic aortic covered stent implantation and aortic aneurysm embolization.A 20mm x 40cm interlock-35 coil was selected for use.During the procedure, when the coil was placed in the aortic aneurysm, the coil was inserted into the 5f angiography catheter.When the coil was pushed out, the coil was stuck in the end catheter and could not be retracted.The physician cut the angiography catheter and clamped the coil with surgical forceps and the procedure was completed with another of the same device.No complications were reported and the patient was stable post-procedure.However, device analysis revealed a detached arm coil.

• Brand Name: INTERLOCK-35
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18955539
• MDR Text Key: 338368406
• Report Number: 2124215-2024-13900
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729795445
• UDI-Public: 08714729795445
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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: 0031852137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• 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 - CORDIS 5F CATHETER
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 62 KG