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

Model Number	39895
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that distal tip detachment occurred.The target lesion was located in the severely calcified femoral artery.A 018/260 platinum plus guidewire was used during the procedure.However, when it was retrieved from the patient, it was noticed that the floppy distal end was not attached to the guidewire.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was not returned by the customer, nevertheless the customer attached a picture.It was observed that the coil wire was stretched.It is important to mention that the device is observed inside the pouch, nevertheless it is not possible to see the entire device.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported that distal tip detachment occurred.The target lesion was located in the severely calcified femoral artery.A 018/260 platinum plus guidewire was used during the procedure.However, when it was retrieved from the patient, it was noticed that the floppy distal end was not attached to the guidewire.No further patient complications were reported.

• Brand Name: PLATINUM PLUS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15546392
• Report Number: 2124215-2022-37873
• Device Sequence Number: 6575315
• Product Code: DQX
• UDI-Device Identifier: 08714729035961
• UDI-Public: 08714729035961
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K935997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: 08/08/2024
• Device Model Number: 39895
• Device Catalogue Number: 39895
• Device Lot Number: 0027804512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown