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

Model Number 83787

Device Problem Premature Activation (1484)

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

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The main coil, the delivery wire, the introducer sheath and the rotating hemostatic valve were returned.Visual inspection revealed that the twist lock was opened.The main coil was found stretched and the interlocking arm detached.The main coil returned separated of the delivery wire, for this reason the functional inspection could not be performance.Under magnification it was possible to observe the interlocking arm detached.

Event Description

Reportable based on device analysis completed on 18jan2023.It was reported that the coil got detached inside the microcatheter.The target lesion was located in the gastroesophageal carices.A 8mm x 20cm interlock-35 was selected for use.During the procedure, while recapturing for repositioning of the coil, it was noted that the coil got detached inside the microcatheter.The coil was withdrawn and the procedure was completed with a different device.No complications were reported and patient was stable post procedure.However, device analysis revealed that the interlocking arm was 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: 16368477
• MDR Text Key: 309477132
• Report Number: 2124215-2023-03605
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793052
• UDI-Public: 08714729793052
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• 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: 0028528885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2021
• 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: DELIVERY CATHETER: COOK 035
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 69 KG