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

Model Number	83779
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A pusher wire, main coil and introducer sheath were returned for this complaint.The twist lock of the introducer sheath had been opened.The introducer sheath was inspected and the tip was found damage.The pusher wire was inspected and was found kinked.The interlocking arm of pusher wire was inspected and was found damage.The coil was returned kinked and stretched near the interlocking arm.The pusher wire was advanced through the introducer sheath without problem, no resistance was felt.The proximal end has a smooth surface.The interlocking arm was inspected and no anomalies were noted.The pusher wire was inspected and was found kinked.The zap tip has a smooth surface.The interlocking arm was inspected and no anomalies were noted.The coil was returned kinked and stretched near the interlocking arm.Dimensional inspection of pusher wire have passed the specification.However, there were a missing fiber bundles from the mail coil and the od of the middle solder joint failed specification.
Event or Problem Description
Reported based on the device analysis completed on 25nov2019.A 14mm x 30cm interlock was selected for use.During the procedure, it was noted that the device was stuck in the microcatheter and could not get out.The coil was removed from the patient's body with the catheter.The procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.However, device analysis revealed that there was a 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: 9438029
• Report Number: 2134265-2019-15286
• Device Sequence Number: 11496444
• Product Code: KRD
• UDI-Device Identifier: 08714729765073
• UDI-Public: 08714729765073
• 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): 12/09/2019

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: 12/21/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0023219861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1