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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The pusher wire, introducer sheath and main coil were returned for this complaint.Visual inspection revealed the twist lock of the introducer sheath had been opened.The introducer sheath was inspected, and no anomalies were noted.The pusher wire was inspected and was found kinked.The main coil was found kinked and stretched.The proximal end has a smooth surface of the pusher wire and the interlocking arm was inspected, and no anomalies were noticed.For the main coil, the proximal end has a smooth surface.The interlocking arm was inspected, and it was detached (part was not returned).Dimensional inspection revealed that for the pusher wire, the overall dimension (od) of the distal solder joint, mid solder joint, distal tfe and proximal tfe matches with the specification.For the main coil, the zap tip (od) and primary coil (od) are within the specification, however, the number of fiber bundles were lacking.
Event or Problem Description
Reportable based on device analysis completed on 30aug2021.It was reported that device was stuck in the catheter.The target lesion was located in the splenic artery.A 3mm x 6cm interlock was selected for use.During the procedure, the coil got stuck in the catheter and prematurely deployed in the protective sheath.The device simply pulled out and the procedure was completed with another of the same.A total of 2 coils were used in the procedure.There were no complications reported and the patient is stable.However, device investigations revealed that the interlocking arm was detached and there were missing fiber bundles.

• 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: 12507170
• Report Number: 2134265-2021-11694
• Device Sequence Number: 16910994
• Product Code: KRD
• UDI-Device Identifier: 08714729764939
• UDI-Public: 08714729764939
• 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): 09/21/2021

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: 01/24/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026859947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR