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

Model Number 83786

Device Problems Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524)

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

Event Date 12/22/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2024.It was reported that the coil could not move forward and withdraw difficultly, resulting the coil stretched after withdrawal.The target lesion was located in the internal iliac artery.A 12mm x 40cm interlock-35 was selected for use.During the procedure, before advancing, the coil was flushed with heparin.When the coil advanced 10cm, the coil could not move forward and withdraw difficultly, resulting the coil stretched after withdrawal.The device was completed with another of the same device.No complications were reported, and the patient was stable post procedure.However, device analysis revealed that the arm coil was detached.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.It was observed that the main coil and the introducer sheath were returned.It was observed that the main coil was bent and stretched at the coil arm and primary coil section.Also, the arm coil was detached.A part of the original box was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed.The functional 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 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: 18817661
• MDR Text Key: 336803484
• Report Number: 2124215-2024-07587
• 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: 03/01/2024

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: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0032004777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• 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: RADIOGRAPHY CATHETER: COOK 5F
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 70 KG