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

Model Number 83779

Device Problem Failure to Advance (2524)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

Reportable based on the device analysis completed on 30nov2023.It was reported that the coil failed to deploy and was stuck.An 12mm x 20cm interlock was selected for use.During the procedure, it was noted that the coil failed to deploy and was stuck inside a non-bsc catheter.Intermittent flushing with saline was used during the procedure while the coil was in the catheter.The procedure was completed with another of the same device.However, device analysis revealed that the coil got detached.

Manufacturer Narrative

E1 - initial reporter phone: (b)(6).Device eval by mfr: the device was returned for analysis.Visual, functional, and dimensional analysis were performed on the device.The main coil, the pusher wire and the introducer sheath were returned for the analysis.It was observed that the main coil was bent, stretched and detached at the coil arm section.The pouch 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.The dimensional inspection revealed that the outer diameter (od) at the zap tip, and primary coil were found to be within specification.

• 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 CORK LIMITED; 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: 18355087
• MDR Text Key: 331195187
• Report Number: 2124215-2023-69749
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2023

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: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0031454101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2023
• 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: PROGREAT (TERUMO) CATHETER