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

Model Number 83779

Device Problems Break (1069); Stretched (1601); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/09/2023

Event Type  Injury  

Event Description

It was reported that a device separation occurred.A 14mm x 50cm interlock was selected for use in a splenic artery aneurysm embolization procedure.8 interlock.018 coils had been previously deployed without issue into the splenic artery aneurysm.However, the last interlock coil would not fully deploy inside aneurysm, so decision was made to re-sheath and remove coil.However, when trying to remove the coil it became detached from the pusher wire.There was no success after attempts were made to advance the coil via wire insertion and flushing.Moreover, when trying to remove the coil, it became stretched and then broke.A small part of the coil remained in the splenic artery.An attempt was performed to remove the detached component but was unsuccessful.Although it did restrict some blood flow through the splenic artery, blood flow to spleen was checked and confirmed.The procedure was completed.There were no patient complications/.

• 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: 17128663
• MDR Text Key: 317172311
• Report Number: 2124215-2023-30381
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729845294
• UDI-Public: 08714729845294
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2023

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: 0029889987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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 Outcome(s): Other