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

Model Number	83786
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection performed.A delivery wire, main coil, and introducer sheath were returned for this complaint.The introducer sheath was inspected, the delivery wire was inside the introducer sheath and the twist lock has been opened.No damaged was noted with the introducer sheath.The main coil and delivery wire were inspected and no anomalies were noted within the delivery wire, nevertheless, the main coil was found kinked, stretched and the interlock arm was detached and it was not received.Functional inspection performed.The delivery wire was advanced through the introducer sheath without problems, no resistance was felt.Microscopic inspection on delivery wire revealed that the proximal end has a smooth surface.The interlocking arm inspected and no damages was found.Microscopic inspection on main coil revealed that the zap tip has a smooth surface.The interlocking arm was detached and it was not returned.Dimensional inspection on the delivery wire that could be measured were performed and were within specification.Dimensional inspection on main coil was performed and revealed that the outer diameter (od) of the zap tip and primary coil were within specification.However, there were lacking no.Of distal and proximal fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 08 jan 2021.It was reported that the coil could not detached.The target lesion was located in the pulmonary artery.An 18mm x 40cm interlock -35 was selected for use.During procedure, the guidewire was advance and catheter was engaged, hydrated continuously and connected to the catheter hub smoothly.However, the coil could not detach when deployed.The device was removed from the catheter.Then, another 15mm x 40mm interlock was advanced distally through the same catheter and noticed to lodged inside before coming out from the catheter tip.The coil was found inside the catheter.The coil was retrieved slowly by pulling it into the long sheath assisted by a snare while inside the catheter.The procedure was completed with a different device.No complications reported and patient was stable.However, device analysis revealed missing fiber bundles and detached interlock arm.

• 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: 11208466
• Report Number: 2134265-2021-00523
• Device Sequence Number: 2191205
• Product Code: KRD
• UDI-Device Identifier: 08714729795414
• UDI-Public: 08714729795414
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K133208
• 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): 01/21/2021

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: 05/01/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0023733376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 55