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

Model Number	39935
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: unit returned with its original and part of the pltinum plus.Guidewire was returned suck in a device that is not from boston scientific.The guidewire was inspected.It was observed that the guidewire was bent and stretched at the distal tip section.The guidewire was also observed to be detached.The pouch was returned, and it was observed that the pouch information matches with the complaint information.Under the microscope it was also confirmed that the guidewire was bent and stretched at the distal tip section and was detached.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that guidewire unraveled occurred.The patient presented with heart failure.During an insertion procedure of a non-boston scientific device, five 3 018/260 platinum plus guidewires were used.However, the wires were unraveled upon insertion.Venogram was performed to make sure that there was no stenosis that the wires were getting stuck in.The approximate location of the damage on the device was through the right internal jugular.All the guidewires were removed intact, and the procedure was completed.No patient complications were reported.However, returned device analysis revealed guide wire detached.
Additional Manufacturer Narrative
H6.Evaluation code corrected to manufacturing deficiency.Device eval by manufacturer: unit returned with its original and part of the pltinum plus.Guidewire was returned suck in a device that is not from boston scientific.The guidewire was inspected.It was observed that the guidewire was bent and stretched at the distal tip section.The guidewire was also observed to be detached.The pouch was returned, and it was observed that the pouch information matches with the complaint information.Under the microscope it was also confirmed that the guidewire was bent and stretched at the distal tip section and was detached.
Event or Problem Description
Reportable based on device analysis completed on 17may2023.It was reported that guidewire unraveled occurred.The patient presented with heart failure.During an insertion procedure of a non-boston scientific device, five 3 018/260 platinum plus guidewires were used.However, the wires were unraveled upon insertion.Venogram was performed to make sure that there was no stenosis that the wires were getting stuck in.The approximate location of the damage on the device was through the right internal jugular.All the guidewires were removed intact, and the procedure was completed.No patient complications were reported.However, returned device analysis revealed guide wire detached.

• Brand Name: PLATINUM PLUS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17100984
• Report Number: 2124215-2023-29184
• Device Sequence Number: 20748957
• Product Code: DQX
• UDI-Device Identifier: 08714729114574
• UDI-Public: 08714729114574
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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: 04/17/2025
• Device Model Number: 39935
• Device Catalogue Number: 39935
• Device Lot Number: 0029239546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2022
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White