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

Model Number 83779

Device Problems Failure to Advance (2524); Separation Failure (2547)

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

Event Date 05/13/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter facility name- (b)(6) hospital device evaluated by manufacturer: the device was returned for analysis.The pusher wire returned inside the introducer sheath.It was observed that the pusher wire was observed kinked and the introducer was detached.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed.Microscope inspection revealed that under the microscope it was observed that the pusher wire was observed kinked and the introducer was detached.The functional inspection could not be performed, because the main coil was not returned.

Event Description

Reportable based on device investigation completed on 20jun2023.It was reported that the coil got stuck in the catheter.The target lesion was in the lower limb artery.A 6mm x 20cm interlock pe f-idc was selected for use.During the procedure, it was noted that this device was advanced smoothly but could not be released.Hence, the coil got stuck in the distal part of the catheter.The coil was retracted inside the catheter again to remove and the entire system was removed.The procedure was completed with a different device.There were no complications reported and the patient is stable.However, device investigations revealed that the introducer was detached.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17321679
• MDR Text Key: 319854394
• Report Number: 2124215-2023-32954
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: 08714729765004
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2023

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: 0030634622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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: GUIDE CATHETER-GUIDEZILLA; MICROCATHETER-COOK 4F SHEATH
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 72 KG