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

Model Number 83786

Device Problems Stretched (1601); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/09/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.The main coil returned inside the introducer sheath, and pusher wire were returned for the analysis.It was necessary to make cuts in the introducer to free the coil.Additionally, it was observed the main coil was stretched and detached at the coil arm section and stretched middle section.No more damages were observed during visual inspection.Under the microscope it was observed that the main coil was stretched and detached at the coil arm section and stretched middle section and zap tip section.The functional inspection could not be performed, because the main coil and the pusher wire are not interlocking.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 (b)(6) 2023.It was reported that the coil could not be advanced from the catheter.An 8mm x 40cm interlock-35 coil was selected for embolization of internal iliac aneurysm.During the procedure, a bsc microcatheter was used to deliver the coil and no perfusion was performed.However, the coil was found to have a problem between the entrance of the delivery system and the break, which could not be pushed further.The microcatheter and the coil were withdrawn from the patient together, and the coil was found to be stretched.The procedure was completed with another of the same device.No complications were reported, and the patent was stable post procedure.However, device analysis revealed that the main coil was detached at the coil arm section.

• 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 CORK LIMITED; 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: 17946462
• MDR Text Key: 325829027
• Report Number: 2124215-2023-55230
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: 08714729793014
• 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: 10/16/2023

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
• Device Operator: Health Professional
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0030284375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2022
• 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
• Patient Age: 60 YR
• Patient Sex: Male