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

Model Number 83779

Device Problems Stretched (1601); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Initial reporter facility name: (b)(6) hospital.Initial reporter address 1: (b)(6).

Event Description

It was reported that the stretched coil remained inside the body.An 8mm x 20cm interlock coil was selected for use in the right renal aneurysm.During the procedure, renal aneurysm embolization was performed with interlock coils, delivered by a microcatheter, and heparin saline perfusion was performed.However, there was obvious resistance when the coil was advanced into the catheter, and it could not continue to be advanced at 2-3cm of the catheter.After the catheter was withdrawn, it was found that coil was stretched, and the stretched part remained in the patient and could not be taken out.The physician tried to withdraw it with a snare, but it failed.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.

• Brand Name: INTERLOCK
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16895788
• MDR Text Key: 314834882
• Report Number: 2124215-2023-20766
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729765011
• UDI-Public: 08714729765011
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132578
• 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: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030284346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2023
• Initial Date FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: MICROCATHETER - STC 18
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female