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

Model Number	83775
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A pusher wire and main coil were returned for this complaint.The coil and pusher wire arms were not interlocked.The pusher wire was inspected and was found kinked.The coil was returned kinked and stretched.The proximal end has a smooth surface.The middle distal solder showed a protuberance.The od of the middle distal solder is out of specification.The interlocking arm was inspected and no anomalies were noted.The zap tip has a smooth surface.The interlocking arm was detached.Dimensional inspection of pusher wire and main coil shows that both have passed the specifications.
Event or Problem Description
Reportable based on the device analysis completed on 25nov2019.The target lesion was located in the gastroduodenal artery.A 4mm x 12cm idc was selected for use.Upon withdrawal, it was noted that the coil unraveled.To remove the unraveled coil the physician hooked the coil with a pusher and the coil was fully removed.The procedure was completed with another of the same device.However, device analysis revealed that interlocking arm was detached.

• Brand Name: IDC
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9437763
• Report Number: 2134265-2019-15278
• Device Sequence Number: 3623106
• Product Code: KRD
• UDI-Device Identifier: 08714729158752
• UDI-Public: 08714729158752
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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: 03/18/2022
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0023665632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• 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