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

Model Number	83787
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A coil and an introducer sheath were returned for this complaint.The twist lock of the introducer sheath was found opened.The introducer sheath was inspected, and no anomalies were noted.The coil was found kinked and stretched.The zap tip has a smooth surface.The interlocking arm was detached.The dimensional inspection revealed that the outer diameter (od) at the zap tip and primary coil were found to be within specification.The distal fiber bundles were also found to be within specification.However, there was proximal fiber bundle loss, due to the stretched coil condition.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that the coil was stretched and got detached.The target lesion was located in the iliac artery.A 8mmx20cm interlock-35 was selected for use.During the procedure, a 20mmx40mm interlock-35 was selected to treat the patient who has maximum tumor diameter of 1.6cm.However, when the coil was deployed, it was found out that it was not so tight.So, a 8mmx20cm coil was used and there was resistance felt, therefore the coil was withdrawn and re-deployed.Consequently, when the coil was withdrawn again, it was noted that the coil was stretched and got detached from the delivery wire.The physician concluded that the size of the coil was too large to deploy, an stc18 microcatheter was used to extend to the position of the tumor.The coil and catheter was withdrawn and the procedure was completed with a different device.There were no patient complications reported and the patient was stable.However, device analysis revealed that the interlocking arm was detached and there were missing fiber bundles.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14229302
• Report Number: 2134265-2022-04201
• Device Sequence Number: 11864107
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

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: 11/10/2023
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0026334468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 65 KG