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

Model Number 83779

Device Problems Stretched (1601); Failure to Advance (2524)

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

Event Date 09/05/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 13nov2023.It was reported that there was obvious resistance, and the coil could no longer be pushed after about half of its release.The target lesion was located in the splenic artery.An 8mm x 20cm interlock was selected for use.During the procedure, it was noted that there was obvious resistance, and the coil could no longer be pushed after about 1/2 of its release.The coil was withdrawn, and it was noted that the coil was stretched.The procedure was completed with another of the same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the main coil was detached.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).E1 - initial reporter address 2: (b)(6).Device evaluated by mfr: only the main coil was returned for the analysis, and it was observed that the main coil was stretched, bent and detached at the middle 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 only the main coil was returned for the analysis.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: 18284044
• MDR Text Key: 329953793
• Report Number: 2124215-2023-64583
• 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: 12/07/2023

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: 0029311613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• 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: EPTECH
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 55 KG