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

Model Number	83787
Medical Device Problem Codes	Break (1069); Stretched (1601); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: the (b)(6) hospital.
Event or Problem Description
It was reported that coil break occurred.The target lesion was located in the pelvic cavity.A 6mm x 20cm cube interlock-35 was advanced for treatment.During the procedure, it was found that the coil could not pushed out of the catheter.After several attempts, the coil interlocking arm was stretched and became detached.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
Event or Problem Description
It was reported that coil break occurred.The target lesion was located in the pelvic cavity.A 6mm x 20cm cube interlock-35 was advanced for treatment.During the procedure, it was found that the coil could not pushed out of the catheter.After several attempts, the coil interlocking arm was stretched and became detached.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.Device evaluated by mfr.: the device was not returned for analysis; nevertheless, there are pictures attached and it is possible to observe three main coils, one is detached at zap tip and arm coil section, the second was bent at primary coil section and the third was bent at zap tip and arm coil 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 CORPORATION; 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: 19075316
• Report Number: 2124215-2024-21522
• Device Sequence Number: 17307811
• Product Code: KRD
• UDI-Device Identifier: 08714729793090
• UDI-Public: 08714729793090
• 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,Followup
• Report Date (Section B): 05/01/2024

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: 08/09/2026
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0032187660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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: ANGIOGRAPHY CATHETER: 5F APT; ANGIOGRAPHY CATHETER: 5F APT
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 65 KG