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

Model Number 83786

Device Problem Difficult to Remove (1528)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2024.It was reported that when the first coil was deployed, it felt like it was in a bad position and could not be withdrawn.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified pulmonary artery.An 8mm x 20cm interlock-35 was selected for use.During the procedure, when the first coil was deployed, it felt like it was in a bad position, and it could not be withdrawn.The coil was withdrawn with the catheter.The procedure was completed with another device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the zap tip was detached.

Manufacturer Narrative

E1; initial reporter facility name - beijing anzhen hospital, capital medical university device evaluated by mfr: the device was returned for evaluation.It was observed that the main coil was bent and stretched at the coil arm and primary coil section.Also, the zap tip was detached.The functional could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection of the pusher wire and main coil revealed the components were within specifications.No other issues were identified during the product analysis.

• 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: 18933182
• MDR Text Key: 338474776
• Report Number: 2124215-2024-12503
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793045
• UDI-Public: 08714729793045
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0029477656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2022
• 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
• Treatment: MICROCATHETER, CORDIS 5F
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 62 KG