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

Model Number 83787

Device Problems Premature Activation (1484); Failure to Advance (2524)

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

Event Date 05/24/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 10jul2023.It was reported that premature deployment occurred.The target lesion was located in the stomach.A 15mm x 40cm interlock.035 was selected for use.During the procedure, it was noted that the interlocking arm of the coil detached/unlocked from the interlocking arm of the pusher wire and could not be advanced.The procedure was completed with another of the same device.No complications were reported, and the patient is stable.However, device investigations revealed that the coil detached at the coil arm section.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The main coil, the introducer sheath and the pusher wire were returned for the analysis; and it was observed that the main coil was stuck inside the introducer, and it was necessary to make cuts to free the coil.The main coil was stretched, bent and detached at the coil arm section.No more damages or issues were observed.Microscope inspection revealed that under the microscope it was observed that the main coil was stretched, bent and detached at the coil arm section.Functional inspection could not be performed due the pusher wire and the main coil are not interlocking.E1.Initial reporter facility (b)(6).

• 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: 17430124
• MDR Text Key: 320239231
• Report Number: 2124215-2023-36388
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: 08714729795438
• 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: 07/31/2023

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: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0028892079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 70 KG