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

Model Number	2779
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Ventricular Fibrillation (2130); Foreign Body In Patient (2687); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/06/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.Vascular access was obtained via the right femoral artery.The 99% stenosed target lesion was located in the severely tortuous and severely calcified circumflex artery.A suspected chronic total occlusion was in the right coronary artery.A 185cm j-tip pt2 guidewire was advanced but failed to cross the right coronary due to a probable chronic occlusion.The guide catheter was changed to a left coronary catheter to approach the circumflex and the pt2 wire was successfully crossed.During removal of this device, the wire broke in the distal coronary followed by dissection in the artery.The wire was not entirely removed.The patient presented with bradycardia and was treated.Ventricular fibrillation occurred and was treated with cardioversion.Vasoactive drugs were started.After 15 to 20 minutes, a balloon was inflated distally and a proximal stent was implanted.The patient subsequently had cardiac arrest and died.
Additional Manufacturer Narrative
Device evaluated by mfr.: the complaint device was not returned for analysis.However, x-ray images were provided.The images are consistent with wire separation associated with dissection in the distal circumflex as alleged in the complaint.There also appears to be a balloon catheter in the mid vessel near where the target lesion was described.
Event or Problem Description
It was reported that patient experienced ventricular fibrillation, vessel dissection, bradycardia, cardiac arrest and died.Vascular access was obtained via the right femoral artery.The 99% stenosed target lesion was located in the severely tortuous and severely calcified circumflex artery.A suspected chronic total occlusion was in the right coronary artery.A 185cm j-tip pt2 guidewire was advanced but failed to cross the right coronary due to a probable chronic occlusion.The guide catheter was changed to a left coronary catheter to approach the circumflex and the pt2 wire was successfully crossed.During removal of this device, the wire broke in the distal coronary followed by dissection in the artery.The wire was not entirely removed.The patient presented with bradycardia and was treated.Ventricular fibrillation occurred and was treated with cardioversion.Vasoactive drugs were started.After 15 to 20 minutes, a balloon was inflated distally and a proximal stent was implanted.The patient subsequently had cardiac arrest and died.
Additional Manufacturer Narrative
Part of a pt2 moderate support guidewire was returned (72.2 inch length).A portion of approximately 0.4 inches of the polymer jacket was not returned for analysis.The guidewire was found fractured.The polymer jacket fracture was confirmed.The outer diameter of the distal, middle of the device, and proximal section were within specifications.The overall length inspection could not be performed due to fracture of the polymer jacket at the distal end of the guidewire.There were images provided which revealed tenuous guide catheter stability as a guide catheter extension device was used.There also appeared to be a balloon catheter in the mid vessel near where the target lesion was described.
Event or Problem Description
It was reported that patient experienced ventricular fibrillation, vessel dissection, bradycardia, cardiac arrest and died.Vascular access was obtained via the right femoral artery.The 99% stenosed target lesion was located in the severely tortuous and severely calcified circumflex artery.A suspected chronic total occlusion was in the right coronary artery.A 185cm j-tip pt2 guidewire was advanced but failed to cross the right coronary due to a probable chronic occlusion.The guide catheter was changed to a left coronary catheter to approach the circumflex and the pt2 wire was successfully crossed.During removal of this device, the wire broke in the distal coronary followed by dissection in the artery.The wire was not entirely removed.The patient presented with bradycardia and was treated.Ventricular fibrillation occurred and was treated with cardioversion.Vasoactive drugs were started.After 15 to 20 minutes, a balloon was inflated distally and a proximal stent was implanted.The patient subsequently had cardiac arrest and died.

• Brand Name: PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10748884
• Report Number: 2134265-2020-14898
• Device Sequence Number: 19598183
• Product Code: DQX
• UDI-Device Identifier: 08714729471202
• UDI-Public: 08714729471202
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2021

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: 01/31/2022
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0025141172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/26/2020; 06/14/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/10/2020; 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR