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

Model Number 83786

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 06/20/2022

Event Type  malfunction  

Event Description

It was reported that the coil protruded from the catheter tip upon removal.The target lesion was located in the severely tortuous internal iliac artery.An 18mm x 20cm interlock-35 coil was selected for use.During the procedure, the device was hydrated intermittently however the coil got stuck inside the distal part of the catheter.Subsequently, the coil was removed together with the catheter and noted protruding at the catheter tip.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: INTERLOCK-35
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15008697
• MDR Text Key: 304019359
• Report Number: 2134265-2022-07761
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729797432
• UDI-Public: 08714729797432
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0024059213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2019
• 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: GUIDEWIRE - SYNCHRO; INTRODUCER SHEATH - DESTINATION