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

Model Number 83786

Device Problems Break (1069); Failure to Advance (2524)

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

Event Date 06/19/2023

Event Type  malfunction  

Event Description

It was reported that the coil was fractured.The target lesion was located in the pulmonary arteriovenous fistula.A 8mm x 40cm.035 interlock 2d coil was selected for use.During the procedure, the device was fully delivered about 4cm, but it was unwound inside the 5f imaging catheter, and the coil got fractured.The device could not be pushed via.35 guidewire or the coil delivery shaft.Therefore, the entire imaging catheter and the coil was withdrawn from the patient.The procedure was completed with a different device.No complications were reported and the patient was stable.

Event Description

It was reported that the coil was fractured.The target lesion was located in the pulmonary arteriovenous fistula.A 8mm x 40cm.035 interlock 2d coil was selected for use.During the procedure, the device was fully delivered about 4cm, but it was unwound inside the 5f imaging catheter, and the coil got fractured.The device could not be pushed via.35 guidewire or the coil delivery shaft.Therefore, the entire imaging catheter and the coil was withdrawn from the patient.The procedure was completed with a different device.No complications were reported and the patient was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Only the main coil was returned for the analysis.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.Under the microscope it was observed that the main coil was stretched and detached at the coil arm section and stretched middle section.The functional inspection could not be performed, because only the main coil returned for the analysis.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17321529
• MDR Text Key: 319767326
• Report Number: 2124215-2023-36573
• 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,Followup
• Report Date: 10/17/2023

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: 0030701966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 60 KG