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

Model Number 83786

Device Problem Failure to Advance (2524)

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

Event Date 07/04/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.Only the main coil was returned for the analysis.Visual and microscopic inspection revealed 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 on the device.The functional test could not be performed due to only the main coil was returned for the analysis.For dimensional inspection of the main coil, the outer diameter of the zap tip and primary coil were within the specification.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that the coil was stuck inside the catheter.The target lesion was in the moderately tortuous left internal iliac artery.A 8mm x 40cm interlock-35 was selected for use.During the procedure, it was noted that the coil was stuck inside the catheter.Hence, as per physicians comment the device was defective.The procedure was completed with another of the same device.No patient complications reported.However, device investigations revealed that the main coil was detached at the coil arm section.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17844134
• MDR Text Key: 324597037
• Report Number: 2124215-2023-49519
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: 08714729793014
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/29/2023

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: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0030021260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• 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