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

Model Number 83786

Device Problems Entrapment of Device (1212); Stretched (1601); Failure to Advance (2524); Material Integrity Problem (2978)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3.Date of event-the event date of (b)(6) 2023 is an estimated based of the aware date of (b)(6) 2023 as the exact date was not reported.

Event Description

It was reported that the coil protruded from catheter tip.The patient was being treated for the mildly tortuous varicose veins in the stomach area.A 12mm x 20cm interlock-35 was inserted through an expect 19 c needle when the coil advanced to the distal part of the needle and got stuck generating a lot of resistance.The entire catheter was removed, but when the coil was pushed out it came out deformed and elongated.The procedure was completed with a different device.No patient complications reported.

• 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 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: 18326051
• MDR Text Key: 330494449
• Report Number: 2124215-2023-70297
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2023

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: 0032323771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• 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 Sex: Male