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

Model Number 83779

Device Problems Difficult to Remove (1528); Stretched (1601); Material Integrity Problem (2978)

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

Event Date 01/12/2024

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 04mar2024.It was reported that the coil was difficult to coil up, was difficult to pull, and the coil was stretched.The target lesion was located in the bronchial artery.A 3mm x 6cm interlock was selected for use.After the bleeding point was found by an angiography catheter, a non-boston scientific microcatheter was used to perform the embolization.During deployment of the coil, it was noted that it was difficult to coil up due to the relatively thin blood vessel.The coil was withdrawn into the sheath, and it was difficult to pull, resulting in the coil being stretched.The microcatheter was pulled back and the procedure was completed with another of the same device.There were no patient complications, and patient was stable post procedure.However, device analysis revealed that the zap tip was detached.

Manufacturer Narrative

Device evaluated by mfr: the main coil, the introducer sheath and the pusher wire were returned for evaluation.It was visually observed that the main coil was bent and stretched.Also, the zap tip was detached, and the coil of the pusher wire was unraveled.The functional inspection could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection of the main coil revealed the components were within specification.No other issues were identified during the product analysis.

• 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 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: 18952534
• MDR Text Key: 338269779
• Report Number: 2124215-2024-14284
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729764939
• UDI-Public: 08714729764939
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0031101758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• 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: MICROCATHETER: STC
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 58 KG