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	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that only the coil was returned for this complaint.The coil was found stretched and kinked.No more damages were found in the device.Microscopic inspection of the main coil revealed that the zap tip was detached and was not returned.The interlocking arm was inspected, and no damages were detected.Dimensional inspection of the main coil revealed the components were within specification.
Event or Problem Description
Reportable based on device analysis completed on 04mar2021.It was reported that the coil could not form a circle.The target lesion was located in the gastric fundus varicose veins.A 12mm x 30cm interlock was selected for use.During procedure, the coil was advanced from the micro catheter and could not form a circle.The coil was withdrawn and redeployed, however it was noted that the coil still could not form a circle.The physician withdrew them all and the procedure was completed with another of same device.No patient complication were reported and patient was stable post procedure.However, device analysis revealed that the tip of the main coil was detached.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11559013
• Report Number: 2134265-2021-03496
• Device Sequence Number: 2955125
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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: 12/01/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024974036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 60