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

Model Number 83786

Device Problems Premature Activation (1484); Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524)

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

Event Date 01/11/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 16feb2023.It was reported that the interlocking arm was prematurely detached.The target lesion was located in the pulmonary arteriovenous fistula.A 12mmx40cm interlock-35 coil was selected for use.During the procedure, upon advancing the device, a resistance was felt mid-section of the catheter and got stuck.Moreover, the interlocking arm got detached and could not be shape again.The device was completely removed together with the catheter.Later, it was found out that the delivery shaft was fractured for about 1cm from the hub and got stretched.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the interlocking arm was detached.

Manufacturer Narrative

Initial reporter address: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.Only the main coil was returned for product analysis.The main coil was stretched and detached at the interlocking arm.Since only the main coil was returned for product analysis the functional test could no to be performance.Under magnification was possible observed the interlocking arm detached.

• 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: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16529520
• MDR Text Key: 311152121
• Report Number: 2124215-2023-08578
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: 08714729792970
• 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: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• 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: 0029343997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2022
• 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: 56 YR
• Patient Sex: Female