MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHOICE PT; WIRE, GUIDE, CATHETER

Model Number	2480
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip detached and remained in the patient.The 95% stenosed lesion was located in the medial left anterior descending artery (lad).Six months prior, ballooning and stenting was performed in the lad and the stent covered the bifurcation to a side branch.The bifurcation lost more than 75% lumen due to a plaque shift.A pt graphix guidewire was introduced to where the stent was placed.The guidewire stopped at the stent and could no longer advance.The shaft of the guidewire was pulled, but the tip detached and remained in the side branch.There were no further patient complications and the patient's status is stable.The event was considered resolved.
Additional Manufacturer Narrative
Device analysis by mfr: the guidewire was returned for analysis.The distal tip was bent and a section of the polymer tip was detached.The detached section was not returned.The damaged section was located approximately at 180.6 cm from the proximal end.No other damages were found in the device.The outer diameter of the middle section and proximal section were within specification.The outer diameter of the distal tip and overall length were unable to be measured due to returned device condition.
Event or Problem Description
It was reported that the tip detached and remained in the patient.The 95% stenosed lesion was located in the medial left anterior descending artery (lad).Six months prior, ballooning and stenting was performed in the lad and the stent covered the bifurcation to a side branch.The bifurcation lost more than 75% lumen due to a plaque shift.A pt graphix guidewire was introduced to where the stent was placed.The guidewire stopped at the stent and could no longer advance.The shaft of the guidewire was pulled, but the tip detached and remained in the side branch.There were no further patient complications and the patient's status is stable.The event was considered resolved.

• Brand Name: CHOICE PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9750750
• Report Number: 2134265-2020-02032
• Device Sequence Number: 16485748
• Product Code: DQX
• UDI-Device Identifier: 08714729141723
• UDI-Public: 08714729141723
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K965023
• 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): 03/27/2020

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: 09/09/2021
• Device Model Number: 2480
• Device Catalogue Number: 2480
• Device Lot Number: 0024409620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/27/2020
• 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: Other