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

Model Number	40295
Medical Device Problem Codes	Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occurred.A.018/260cm platinum plus guidewire was selected for use.However, prior to procedure, it was noticed that the device arrived with inner seal compromised, packaging was damaged, and the box was crumbled and looked like a dried cardboard.No patient complications were reported.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
Device media analysis: the complaint device was not returned by the customer; nevertheless, the customer did provide pictures related to the complaint.The photo shows the original box with damage and wrinkles; consequently, confirming the reported complaint related to packaging damaged/defective.It is important to mention that only the outer box was visible at photo attached; therefore, the original pouch was not visible.Consequently, the reported complaint related to foil pouch seal compromised was not confirmed.
Event or Problem Description
It was reported that device contamination occurred.A.018/260cm platinum plus guidewire was selected for use.However, prior to procedure, it was noticed that the device arrived with inner seal compromised, packaging was damaged, and the box was crumbled and looked like a dried cardboard.No 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14552554
• Report Number: 2134265-2022-05703
• Device Sequence Number: 12420401
• Product Code: DQX
• UDI-Device Identifier: 08714729326212
• UDI-Public: 08714729326212
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K945379
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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: 02/06/2025
• Device Model Number: 40295
• Device Catalogue Number: 40295
• Device Lot Number: 0028821762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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 Sex: Unknown