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

Model Number	2777
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred and remains in the patient.A 185cm moderate support straight pt2 guidewire was advanced for treatment.However, at the end of the angiogram, it was noticed that there was a radiopaque portion showing on the cineangiography.When the pt2 wire was checked, it was noticed that the distal end of the wire had fractured off.A surgical consultant was then called to evaluate, and it was decided to leave the fragment in one of the diagonals of a vessel as it was not causing any issues to the patient.The procedure was completed successfully, and the patient was monitored extensively post procedure and there were no patient complications reported.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Street device evaluated by mfr.: the complaint device was not returned by the customer, a photo of the complaint device was received for analysis.In the photo was possible to observe the distal tip of the guidewire, detached.Due to the device was not returned no product analysis could be performed.Device was not returned for analysis.
Event or Problem Description
It was reported that tip detachment occurred and remains in the patient.A 185cm moderate support straight pt2 guidewire was advanced for treatment.However, at the end of the angiogram, it was noticed that there was a radiopaque portion showing on the cineangiography.When the pt2 wire was checked, it was noticed that the distal end of the wire had fractured off.A surgical consultant was then called to evaluate, and it was decided to leave the fragment in one of the diagonals of a vessel as it was not causing any issues to the patient.The procedure was completed successfully, and the patient was monitored extensively post procedure and there were no patient complications reported.
Event or Problem Description
It was reported that tip detachment occurred and remains in the patient.A 185cm moderate support straight pt2 guidewire was advanced for treatment.However, at the end of the angiogram, it was noticed that there was a radiopaque portion showing on the cineangiography.When the pt2 wire was checked, it was noticed that the distal end of the wire had fractured off.A surgical consultant was then called to evaluate, and it was decided to leave the fragment in one of the diagonals of a vessel as it was not causing any issues to the patient.The procedure was completed successfully, and the patient was monitored extensively post procedure and there were no patient complications reported.The complaint device was not returned by the customer, nevertheless the customer did provide one picture related to the complaint in the attachments of the complaint #: (b)(4).In the photo was possible to observe the distal tip of the guidewire, detached.Due to the device was not returned no product analysis could be performed.If the complaint device is returned later, the investigation will be opened in order to address the additional evidence.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: unit returned with its original pouch batch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.In the photo was possible to observe the distal tip of the guidewire, detached.No failures were found on the device and on the distal tip.The device was measured in three sections (distal - medium - proximal) along it in order to confirm that is within specification.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: the complaint device was not returned by the customer, nevertheless the customer did provide one picture related to the complaint in the attachments of the complaint.In the photo was possible to observe the distal tip of the guidewire, detached.Due to the device was not returned no product analysis could be performed.If the complaint device is returned later, the investigation will be opened in order to address the additional evidence.
Event or Problem Description
It was reported that tip detachment occurred and remains in the patient.A 185cm moderate support straight pt2 guidewire was advanced for treatment.However, at the end of the angiogram, it was noticed that there was a radiopaque portion showing on the cineangiography.When the pt2 wire was checked, it was noticed that the distal end of the wire had fractured off.A surgical consultant was then called to evaluate, and it was decided to leave the fragment in one of the diagonals of a vessel as it was not causing any issues to the patient.The procedure was completed successfully, and the patient was monitored extensively post procedure and there were no patient complications reported.

• 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: 14437738
• Report Number: 2134265-2022-05682
• Device Sequence Number: 5579729
• Product Code: DQX
• UDI-Device Identifier: 08714729471196
• UDI-Public: 08714729471196
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2023
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0027426166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 06/06/2022; 07/11/2022; 08/04/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/27/2022; 08/01/2022; 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown