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

Model Number	2783
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age at time of event: 18 years or older.
Event or Problem Description
It was reported that guidewire break occurred.A 300cm pt2 moderate support guidewire was selected for used.However, during preparation, a guidewire breakage was identified upon retraction of the packaging, and the device was unable to be used.The procedure was completed with another of same device.No patient complications were reported and the patient condition post procedure was stable.
Event or Problem Description
It was reported that guidewire break occurred.A 300cm pt2 moderate support guidewire was selected for used.However, during preparation, a guidewire breakage was identified upon retraction of the packaging, and the device was unable to be used.The procedure was completed with another of same device.No patient complications were reported and the patient condition post procedure was stable.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.The device was returned for analysis.Visual inspection revealed multiple kinks noted in the body of the guidewire.Microscopic inspection showed no signs of detachment in the ends of the guidewire.Dimensional testing showed the device length met specification.

• Brand Name: PT
• 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: 15621729
• Report Number: 2124215-2022-41997
• Device Sequence Number: 20419447
• Product Code: DQX
• UDI-Device Identifier: 08714729471257
• UDI-Public: 08714729471240
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030617
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

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: 12/15/2023
• Device Model Number: 2783
• Device Catalogue Number: 2783
• Device Lot Number: 0028561428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• 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