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

Model Number	39935
Medical Device Problem Codes	Difficult to Remove (1528); 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
Event or Problem Description
It was reported that guidewire removal difficulties 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.The physician had to remove the sheath and wire together at one point just to remove a guidewire.All the guidewires were removed intact, and the procedure was not completed.No patient complications were reported.
Event or Problem Description
It was reported that guidewire removal difficulties 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.The physician had to remove the sheath and wire together at one point just to remove a guidewire.All the guidewires were removed intact, and the procedure was not completed.No patient complications were reported.
Additional Manufacturer Narrative
The complaint device was not returned by the customer; nevertheless, the costumer did provide one photo related to the complaint, and it is possible to see that the pouch information matches with complaint information.Also, the guidewire was observed inside the pouch, and it was bent/kinked at distal section.Is important to mention that the pouch that there is no evidence on the pictures that the pouch was closed.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Additional Manufacturer Narrative
Device evaluated by manufacturer: unit returned with its original pouch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The complaint device was returned by the customer; nevertheless, physician has provided pictures of the device.As per pictures provided, it can be observed that the guidewire was bent and stretched at the distal tip section.In the picture it is possible to see that the pouch information matches with the complaint information.The guidewire was returned and, it was observed that the guidewire was bent and stretched at the distal tip section.The pouch was returned, and it was observed that the pouch information matches with the complaint information.Under the microscope it was observed that the guidewire was bent and stretched at the distal tip section.The complaint device was not returned by the customer; nevertheless, the costumer did provide one photo related to the complaint, and it is possible to see that the pouch information matches with complaint information.Also, the guidewire was observed inside the pouch, and it was bent/kinked at distal section.Is important to mention that the pouch that there is no evidence on the pictures that the pouch was closed.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported that guidewire removal difficulties 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.The physician had to remove the sheath and wire together at one point just to remove a guidewire.All the guidewires were removed intact, and the procedure was not completed.No patient complications were reported.

• 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: 16587825
• Report Number: 2124215-2023-10667
• Device Sequence Number: 20307199
• 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,Followup
• Report Date (Section B): 06/05/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 03/25/2023; 05/16/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/07/2023; 06/07/2023
• 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