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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A pusher wire, coil and introducer sheath were returned for this complaint.The coil and pusher wire arms were interlocked within introducer sheath.The introducer sheath was inspected and no anomalies were noted.The twist lock of the introducer sheath had been opened.The pusher wire was inspected and no anomalies were noted.The coil was returned stretched in the middle of the core.No more damages were found in the returned device.The pusher wire was advanced through the introducer sheath without problems, no resistance was felt.The proximal end has a smooth surface.The interlocking arm was inspected and no anomalies were noted.The zap tip has a smooth surface.The interlocking arm was inspected and no anomalies were noted.Dimensional inspection of the pusher wire and main coil revealed the components were within specification except the number of fiber bundles, which were only 13 out of 25.
Event or Problem Description
Reportable based on device analysis completed on 17jan2020.It was reported that the coil was stuck in the catheter.The target lesion was located in a hepatic artery.A 5mm x 8cm interlock coil was selected for use.During procedure, it was noted that the coil was stuck in the middle part of the catheter and it could not be pushed or withdrawn.Furthermore, the coil became stretched.The coil was removed within the catheter all together and the procedure was completed with another of the same device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that 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: 9681716
• Report Number: 2134265-2020-01064
• Device Sequence Number: 2756348
• Product Code: KRD
• UDI-Device Identifier: 08714729764977
• UDI-Public: 08714729764977
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/07/2020

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: 12/18/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0023210622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 70