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

Model Number	83779
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the coil was removed by a snare.The stenosed target lesion was located in the intra-iliac veins.An 8mm x 20cm interlock was selected for use.During the procedure, when the coil was deployed and reached the lesion site, it was found that the coil could not be coiled and controlled for many attempts.The coil was removed by a snare.The procedure was completed with another interlock.There were no complications reported and the patient was stable post procedure.
Event or Problem Description
It was reported that the coil was removed by a snare.The stenosed target lesion was located in the intra-iliac veins.An 8mm x 20cm interlock was selected for use.During the procedure, when the coil was deployed and reached the lesion site, it was found that the coil could not be coiled and controlled for many attempts.The coil was removed by a snare.The procedure was completed with another interlock.There were no complications reported and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device eval by mfr: only the main coil was returned for the analysis.It was observed that the main coil was bent at the middle section.No more damages were observed.The functional could not be performed due only the main coil was returned for the analysis.The dimensional inspection revealed that the outer diameter (od) at the coil arm, zap tip and primary coil were found to be within specification.

• 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: 17820619
• Report Number: 2124215-2023-48161
• Device Sequence Number: 6100990
• Product Code: KRD
• UDI-Device Identifier: 08714729765011
• UDI-Public: 08714729765011
• 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): 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0028615682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 66 KG