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

Model Number	83787
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).E1 initial reporter state: (b)(6).Device evaluated by mfr: the device was returned for analysis.Only the main coil returned for the analysis; and it was observed that the main coil was kinked, stretched and detached at the coil arm section.A part of the original box was returned, and it was observed that the pouch information matches with the complaint information.No more damages or issues were observed.Under the microscope it was observed that the main coil was kinked, stretched and detached at the coil arm section.Functional inspection test could not be performed due the pusher wire was not returned to this complaint.Dimensional inspection of the zap tip and primary coil outer diameter met specifications.However, the coil arm outer diameter failed to meet specification.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that the coil could not advance the catheter.The target lesion was located in the internal iliac artery.A 8mm x 20cm interlock.035 coil was selected for use.During the procedure, the physician successively deployed two 35 system coils of 12mmx40cm and 10x40, and then continued to deploy a 35 system coil of 8x20.However, this coil was stuck in the posterior section of the angiography catheter.The physician could not advance it after several attempts.Then, the coil was withdrawn, and the procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post procedure.However, device analysis revealed that the coil detached at the arm section.

• Brand Name: INTERLOCK-35
• 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: 17455012
• Report Number: 2124215-2023-37283
• Device Sequence Number: 7383159
• Product Code: KRD
• UDI-Device Identifier: 08714729793052
• UDI-Public: 08714729793052
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2023

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: 06/01/2025
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0029517716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 86 KG