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

Model Number	83786
Medical Device Problem Codes	Separation Failure (2547); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by mfr: upon receipt at our post market quality assurance laboratory, this.035 interlock coil was thoroughly analyzed.Visual examination revealed that the main coil was bent and stretched at arm coil, zap tip and primary coil section.The arm coil and zap tip were detached.Functional testing could not be performed as the main coil and pusher wire were not interlocking.Dimensional analysis revealed no damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 21may2024.It was reported that the coil could not be deployed.An.035 interlock coil was selected for use in a splenic embolization procedure.During the procedure, the.035 interlock could not be deployed.The coil was removed and exchanged for a new coil and microcatheter.The procedure was completed.There were no patient complications.However, device analysis revealed the coil was detached.
Additional Manufacturer Narrative
H6 evaluation conclusion codes: corrected to 'adverse event related to procedure' from 'no problem detected'.Device eval by mfr: upon receipt at our post market quality assurance laboratory, this.035 interlock coil was thoroughly analyzed.Visual examination revealed that the main coil was bent and stretched at arm coil, zap tip and primary coil section.The arm coil and zap tip were detached.Functional testing could not be performed as the main coil and pusher wire were not interlocking.Dimensional analysis revealed no damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 21may2024.It was reported that the coil could not be deployed.An.035 interlock coil was selected for use in a splenic embolization procedure.During the procedure, the.035 interlock could not be deployed.The coil was removed and exchanged for a new coil and microcatheter.The procedure was completed.There were no patient complications.However, device analysis revealed the coil was detached.

• 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: 19440098
• Report Number: 2124215-2024-33150
• Device Sequence Number: 8456467
• Product Code: KRD
• UDI-Device Identifier: 08714729793045
• UDI-Public: 08714729793045
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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 Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0032764512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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
• Patient Sex: Unknown