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

Model Number 83787

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 05feb2024.It was reported that the coil was stuck.The target lesion was in the internal iliac artery.A 20mm x 40cm interlock-35 was selected for use.During the procedure, a total of three coils were used.However, when this coil was advanced halfway it could not be pushed forward so the physician tried to withdraw it, but it got stuck.The device was withdrawn from the patient together with the delivery system and the procedure was completed with another of the same angiography catheter and another of the same device.There were no complications reported and the patient was stable.However, device investigations revealed that the arm coil was detached.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.For visual inspection, it was observed that the main coil, the introducer sheath and the pusher wire were returned.It was observed that the main coil was bent and stretched at the primary coil section.Also, the arm coil was detached.No more damages were observed.The functional could not be performed due that only the main coil was returned.For dimensional inspection, the outer diameter of the zap tip, primary coil and coil arm of the main coil were within specification.

• 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 CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18792983
• MDR Text Key: 336412908
• Report Number: 2124215-2024-06576
• Device Sequence Number: 1
• Product Code: KRD
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0031050027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2023
• 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: CORDIS. 5F CATHETER
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 65 KG