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

Model Number 83779

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A coil and introducer sheath were returned for this complaint.Visual inspection was performed and it was found that the coil was exiting from the introducer sheath.The twist lock of the introducer sheath was found opened.The introducer sheath was inspected and no anomalies was noted.The coil was returned kinked and stretched.No more damages were found in the device.Functional inspection was performed and the main coil was tried to advance through the introducer sheath, but it was not possible to continue advancing due to the main coil was stuck; it was necessary to cut the sheath in order to release the main coil.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Dimensional inspection of the zap tip outer diameter (od) and the primary coil od were performed and were within specifications.However, dimensional inspection of the number of fiber bundles revealed missing coil fiber bundles and does not meet specification.The number of fiber bundles loss due to the coil condition.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 02nov2020.It was reported that the coil detached prematurely inside the catheter.Three interlock coils of different sizes, namely, two 18mmx50cm and one 14mmx30cm, were selected for use on the pulmonary artery aneurysm.During the procedure, after framing with 5 targets, two 18mmx50cm interlock coils were inserted.However, it was noted that both coils detached prematurely inside the catheter.Then, another coil of unknown size was inserted and deployed successfully.Then, this coil was inserted.However, it was noted that the coil also detached prematurely inside the catheter.The coils that detached prematurely were removed with the catheter and the procedure was completed with another of the same device.It was noted that the coils that detached prematurely did not protrude in the catheter's tip during removal.No complications were reported and there was no patient injury.However, device analysis revealed missing coil 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: 10817449
• MDR Text Key: 215541082
• Report Number: 2134265-2020-15552
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729765073
• UDI-Public: 08714729765073
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0025082607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2020
• 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
• Treatment: MICROCATHETER - BREAKTHROUGH2M