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

Model Number 83779

Device Problems Entrapment of Device (1212); Stretched (1601); Failure to Advance (2524)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

It was reported that part of the coil protruded from catheter tip upon removal.The target lesion was in the arteriovenous fistula.A 8mm x 20cm pe f-idc interlock was selected for use.During the procedure, it was noted that the coil was pushed into the microcatheter, a great resistance was felt.The coil could not be pushed out after being pushed halfway.After repeated attempts, it still could not be pushed out into the distal of the catheter.The device was removed from the patient together with the catheter with part of the coil protruding from the catheter tip.It was also found that the coil had been stretched upon removal.The procedure was completed with another of the same device.No complications reported and the patient was in stable condition after procedure.

Event Description

It was reported that part of the coil protruded from catheter tip upon removal.The target lesion was in the arteriovenous fistula.A 8mm x 20cm pe f-idc interlock was selected for use.During the procedure, it was noted that when the coil was pushed into the microcatheter, a great resistance was felt.The coil could not be pushed out after being pushed halfway.After repeated attempts, it still could not be pushed out into the distal end of the catheter.The device was removed from the patient together with the catheter with part of the coil protruding from the catheter tip.It was also found that the coil had been stretched upon removal.The procedure was completed with another of the same device.No complications were reported and the patient was in stable condition after procedure.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.Visual inspection revealed that only the main coil was returned.It was observed that the main coil was bent and stretched at the primary and zap tip section.Functional testing could not be performed since only the main coil was returned.The coil arm outer diameter (od), zap tip od, and primary coil od passed the dimensional inspection.

• 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: 18732259
• MDR Text Key: 335749932
• Report Number: 2124215-2024-06157
• Device Sequence Number: 1
• Product Code: KRD
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• 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: 0030597536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2022
• 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-HIDA ASAHI STD125-26S; MICROCATHETER-HIDA ASAHI STD125-26S
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 65 KG