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

Model Number 83779

Device Problems Entrapment of Device (1212); Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2021

Event Type  malfunction  

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 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
• Type of Device: 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: 12507170
• MDR Text Key: 272519060
• Report Number: 2134265-2021-11694
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729764939
• UDI-Public: 08714729764939
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR