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

Model Number	83779
Medical Device Problem Codes	Failure to Advance (2524); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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was advanced smoothly but could not be released.Hence, the coil got stuck in the distal part of the catheter.The coil was retracted inside the catheter again to remove and the entire system was removed.The procedure was completed with a different device.There were no complications reported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
• Common Device Name: 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
• Report Number: 2124215-2023-32954
• Device Sequence Number: 6913096
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: 08714729765004
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER-GUIDEZILLA; MICROCATHETER-COOK 4F SHEATH
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 72 KG