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

Model Number	83779
Medical Device Problem Codes	Break (1069); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1:(b)(6).
Event or Problem Description
It was reported that the coil was broken.A 12mm x 30cm interlock coil was selected for embolization of gastric fundus vein.During the procedure, the 5f angiographic catheter was accessed to the lesion position via vein, and the coil was advanced to the embolization position but could not deploy during delivery.The coil was simply pulled out; however, the coil was found to be broken when it was withdrawn.The procedure was completed with another of the same device.No patient complications were reported, and the patient was stable post-procedure.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the complaint device was received for product analysis.The pusher wire and the introducer sheath were returned for the analysis; no damages were observed.The functional could not be performed due the main coil was not returned for the analysis.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the coil was broken.A 12mm x 30cm interlock coil was selected for embolization of gastric fundus vein.During the procedure, the 5f angiographic catheter was accessed to the lesion position via vein, and the coil was advanced to the embolization position but could not deploy during delivery.The coil was simply pulled out; however, the coil was found to be broken when it was withdrawn.The procedure was completed with another of the same device.No patient complications were reported, and the patient was stable post-procedure.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17925416
• Report Number: 2124215-2023-53871
• Device Sequence Number: 2982818
• Product Code: KRD
• UDI-Device Identifier: 08714729765059
• UDI-Public: 08714729765059
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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: 10/23/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030592233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 65 KG