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

Model Number	81735
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	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that product package seal was compromised.When a 135cm model-transend guidewire was arrived; it was noted that the box was flattened, and the seal was peeled off.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned inside its respective original box.It was observed that the closure strip of the box was opened.After taking the pouch out of the box, it was observed that the original pouch was sealed, and the device was observed without any damage.Additionally, it was observed that the original box has ripped and had wrinkles.The pouch was returned, and it was observed that the pouch information matches with the complaint information.
Event or Problem Description
It was reported that product package seal was compromised.When a 135cm model-transend guidewire was arrived; it was noted that the box was flattened, and the seal was peeled off.There were no patient complications reported.

• Brand Name: TRANSEND
• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16303322
• Report Number: 2124215-2023-03125
• Device Sequence Number: 6075133
• Product Code: DQX
• UDI-Device Identifier: 08714729326274
• UDI-Public: 08714729326274
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K941710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: 10/13/2024
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0030349736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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