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

Model Number	83786
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device fractured.The target lesion area was located in the coronary veins of the stomach.A 2d.035 8mmx20cm interlock.035 embolics was selected for use in the embolization of the gastric coronary vein.During the procedure, the second coil was advanced a little and the position was adjusted by re-advancing the device.However, it was noted that the interlocking arms was fractured, and stretched.The device was simply removed from the patient's body and the procedure was completed with another of same device.There were no complications reported and the patient is stable.
Event or Problem Description
It was reported that the device fractured.The target lesion area was located in the coronary veins of the stomach.A 2d.035 8mmx20cm interlock.035 embolics was selected for use in the embolization of the gastric coronary vein.During the procedure, the second coil was advanced a little and the position was adjusted by re-advancing the device.However, it was noted that the interlocking arms was fractured, and stretched.The device was simply removed from the patient's body and the procedure was completed with another of same device.There were no complications reported and the patient is stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that only the main coil was returned for this complaint.The coil was found kinked and stretched.No more damages were found.Microscopic inspection of the main coil revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and it was detached (part not returned).Dimensional inspection of the main coil that could be measured were performed and were within specification.

• 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
• MDR Report Key: 11279780
• Report Number: 2134265-2021-01191
• Device Sequence Number: 14125512
• Product Code: KRD
• UDI-Device Identifier: 08714729793045
• UDI-Public: 08714729793045
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 07/14/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0025715461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 67