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

Model Number 83786

Device Problems Break (1069); Premature Activation (1484); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/08/2023

Event Type  Injury  

Event Description

It was reported that coil detachment occurred, snare was attempted but coil still remained inside the body.The target lesion was located in the mildly tortuous pulmonary artery.An 8mm x 20cm interlock-35 was selected for use.During the procedure, the coil did not deploy correctly.Resistance was met and the coil was unable to pull or push to recapture the device.Most of the coil was pushed out into the desired location, however, when the catheter was pulled back, it was noted that a string of the coil was pulled back into the pulmonary artery.Physician's thought that it looked like that some of the pusher wire was on it too but it was unclear.The coil was tried to be snared out but it was unable to and was left inside the body, patient was under monitoring.No further patient complications were reported.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17033564
• MDR Text Key: 316255203
• Report Number: 2124215-2023-25136
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793045
• UDI-Public: 08714729793045
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0029720153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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): Required Intervention; Other
• Patient Sex: Female