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

Model Number 83787

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

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

Event Date 07/03/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 04sep2023.It was reported that the coil was stuck inside the catheter.A 20mm x 40cm interlock-35 coil was selected for transjugular intrahepatic portosystemic shunt (tips).During the procedure, the 5f cordis imaging catheter was used to deploy the 35 coils.However, it was noted that the coil was stuck inside the catheter which could neither be advanced nor be withdrawn.The entire imaging catheter was then removed, and the procedure was completed with a different device.No complications were reported, and the patient was stable post procedure.However, device analysis revealed that the main coil was detached at the coil arm section.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Only the main coil was returned for analysis.And the evaluation was completed on 04sep2023.Visual examination was performed and revealed that the main coil was stretched, detached and bent at the coil arm section.No more damages can be observed on the device during visual examination.Under the microscope it was observed that the main coil was stretched, detached and bent at the coil arm section.The functional test 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 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 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: 17801524
• MDR Text Key: 324126204
• Report Number: 2124215-2023-50739
• 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: 09/22/2023

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: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0030920900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2023
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 66 KG