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

Model Number	2080
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via facility medwatch report mw5114593 that guidewire distal tip detachment occurred.The patient was being treated for angiogram in right lower extremity.A 300cm, 8cm poly tip v-18 control wire was selected for use.However, during procedure, the tip of an angiogram wire detached in patient's lower leg artery.Another 300 pt es (5pk) choice wire was selected for use; however, the tip of wire also detached in patient's lower leg artery.A microcatheter gooseneck was advance to snare down the anterior tibial artery but could not get it passed the proximal portion of the artery due to the high degree of calcification.In addition, the v-18 wire was distally advance into the anterior tibial artery was able to get the tip of this wire to coil up and was pulled back through the detached choice wire and capture it back to the sheath above the knee popliteal artery.A micro catheter gooseneck snare was used into the sheath and was able to retrieve the distal tip of the choice pt wire.Both devices were retrieved and removed.A significant calcification in the artery may have contributed to the event.No patient complications were reported, and the patient was in stable condition.
Event or Problem Description
It was reported via facility medwatch report mw5114593 that guidewire distal tip detachment occurred.The patient was being treated for angiogram in right lower extremity.A 300cm, 8cm poly tip v-18 control wire was selected for use.However, during procedure, the tip of an angiogram wire detached in patient's lower leg artery.Another 300 pt es (5pk) choice wire was selected for use; however, the tip of wire also detached in patient's lower leg artery.A microcatheter gooseneck was advance to snare down the anterior tibial artery but could not get it passed the proximal portion of the artery due to the high degree of calcification.In addition, the v-18 wire was distally advance into the anterior tibial artery was able to get the tip of this wire to coil up and was pulled back through the detached choice wire and capture it back to the sheath above the knee popliteal artery.A micro catheter gooseneck snare was used into the sheath and was able to retrieve the distal tip of the choice pt wire.Both devices were retrieved and removed.A significant calcification in the artery may have contributed to the event.No patient complications were reported, and the patient was in stable condition.It was further reported that a 014 choice pt wire was advanced down the non-bsc catheter into the anterior tibial artery (ata).A non-bsc catheter was removed and another 014 non-bsc catheter was advanced over the choice pt wire.Afterwards, an attempt was made to cross the occluded segment of distal ata using the 014 choice pt wire which causes the distal tip of the wire broke off.Furthermore, while trying to remove and retrieved the device, the distal tip of the v-18 wire dislodged and migrated into the tibioperoneal trunk.A microcloverleaf snare was used to successfully retrieve the device.A scanned was performed on the patient under fluoroscopy and confirmed that there was no residual wire tip left behind.
Event or Problem Description
It was reported via facility medwatch report (b)(4) that guidewire distal tip detachment occurred.The patient was being treated for angiogram in right lower extremity.A 300cm, 8cm poly tip v-18 control wire was selected for use.However, during procedure, the tip of an angiogram wire detached in patient's lower leg artery.Another 300 pt es (5pk) choice wire was selected for use; however, the tip of wire also detached in patient's lower leg artery.A microcatheter gooseneck was advance to snare down the anterior tibial artery but could not get it passed the proximal portion of the artery due to the high degree of calcification.In addition, the v-18 wire was distally advance into the anterior tibial artery was able to get the tip of this wire to coil up and was pulled back through the detached choice wire and capture it back to the sheath above the knee popliteal artery.A micro catheter gooseneck snare was used into the sheath and was able to retrieve the distal tip of the choice pt wire.Both devices were retrieved and removed.A significant calcification in the artery may have contributed to the event.No patient complications were reported, and the patient was in stable condition.It was further reported that a 014 choice pt wire down the bernstein catheter into the anterior tibial artery then bernstein catheter was removed and advanced a 014 cxi catheter over the choice pt wire.Afterwards, an attempt was made to cross the occluded segment of distal anterior tibial artery using the 014 choice pt wire which causes the distal tip of the wire broke off.Furthermore, while trying to remove and retrieved the device, the distal tip of the av 18 wire dislodged and migrated into the tibioperoneal trunk.A microcloverleaf snare was used to successfully retrieve the device.A scanned was performed on the patient under fluoroscopy and confirmed that no residual wire tip left behind.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device was observed kinked.Distal tip was observed detached.

• Brand Name: CHOICE PT
• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16409468
• Report Number: 2124215-2023-06557
• Device Sequence Number: 14294006
• Product Code: DQX
• UDI-Device Identifier: 08714729177012
• UDI-Public: 08714729177012
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2023

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: 10/26/2024
• Device Model Number: 2080
• Device Catalogue Number: 2080
• Device Lot Number: 0030437942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 02/24/2023; 04/18/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/09/2023; 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown