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

Model Number 83787

Device Problem Failure to Advance (2524)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the main coil and the introducer sheath were returned, and both were damaged.It was observed that the main coil was bent, stretched and detached at the coil arm, zap tip and the primary coil section.Also, the introducer sheath was detached at twist-lock section.The functional could not be performed due the pusher wire not returned.Dimensional inspection of the main coil revealed the components were within specification.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 05mar2024.It was reported that the coil could not come out at the exit of the catheter and was unable to continue to be pushed.The target lesion was located in the renal vein.A 20mm x 40cm interlock-35 was selected for use.During the procedure, perfusion with heparin saline and continuous flushing was performed.However, it was noted that the coil could not come out at the exit of the catheter and was unable to continue to be pushed.The device was withdrawn, and the procedure was completed with another of the same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the main coil was detached at the coil arm.

• 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: 19003578
• MDR Text Key: 338986011
• Report Number: 2124215-2024-14487
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729795445
• UDI-Public: 08714729795445
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 0030634686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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 Age: 67 YR
• Patient Sex: Female