MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PLATINUM PLUS; WIRE, GUIDE, CATHETER

Model Number	39935
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.The target lesion was located in an artery of the foot.A 018/180 platinum plus guide wire was advanced to cross the lesion.However, after dilation of the vessel, the tip of the guidewire broke between 5 and 7cm and remained in the vessel.The artery is not very permeable per doppler.An attempt to recover the broken tip by lasso was performed, but it turned out to be impossible.No further patient complications were reported.
Event or Problem Description
It was reported that guidewire tip detachment occurred.The target lesion was located in an artery of the foot.A 018/180 platinum plus guide wire was advanced to cross the lesion.However, after dilation of the vessel, the tip of the guidewire broke between 5 and 7cm and remained in the vessel.The artery is not very permeable per doppler.An attempt to recover the broken tip by lasso was performed, but it turned out to be impossible.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: visual examination of the returned device revealed the spring tip was damaged.The damage was in the form of unraveling, and the core wire was fractured at the distal end.Dimensional inspection revealed the outer diameters of the device proximal, middle, and tip sections were all within specifications.Apart from the observed damage, inspection presented no other issues or irregularities.

• Brand Name: PLATINUM PLUS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8302713
• Report Number: 2134265-2019-00737
• Device Sequence Number: 1649874
• Product Code: DQX
• UDI-Device Identifier: 08714729114567
• UDI-Public: 08714729114567
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K935997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2021
• Device Model Number: 39935
• Device Catalogue Number: 39935
• Device Lot Number: 0022446043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 91