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

Model Number	83779
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Only the coil was returned for this complaint.Visual inspection was performed and revealed that the coil was kinked and stretched.The interlocking arm was detached and it was not returned.No more damages were found in the device.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.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 were less due to the coil condition.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 30oct2020.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, this coil and another of the same size 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, a 14mmx30cm interlock 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 an interlocking arm detached and missing coil 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: 10817468
• Report Number: 2134265-2020-15519
• Device Sequence Number: 1926389
• Product Code: KRD
• UDI-Device Identifier: 08714729845300
• UDI-Public: 08714729845300
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

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: 05/03/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0025555673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER - BREAKTHROUGH2M