MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number 3520

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Perforation of Vessels (2135); Pseudoaneurysm (2605)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

Age at time of event (b)(6) years old.Date of event is an estimated date based off the aware date as the exact event date was not reported.

Event Description

It was reported that pseudoaneurysm from coronary perforation occurred.The 99% stenosed target lesion area was located in the severely calcified mid right coronary artery (rca).The rca was considered to be the responsible lesion since the contrast delay was observed here during cag.A 1.50mm rotalink plus and a 330cm rotawire were used in a percutaneous coronary intervention (pci).During procedure, after the guidewire passed through, poba was performed from rca mid to the atrioventricular branch (av branch).Unfortunately, imaging device only managed to cross up to the rca mid and it was decided to perform rotablation.Rota wire floppy then replaced the guidewire and ablation was performed using a 1.50mm burr from rca mid to av branch, however perforation of the coronary artery occured due to a tortuous area during movement from the dista rca to the av branch.Hemostasis was carried out after poba at the affected area, an intra aortic balloon pump (iabp) was placed.The groin/inguinal area was punctured to gain vascular access for the covered stent to be advanced, and used a double guide method.The covered stent was then advanced by balloon that traps the guidewire but advancement was unsuccessful.Subsequently, it was noted that cardiac fluid did not increase and decrease in the blood pressure that time.A coronary artery bypass was performed semi-urgently with iabp placed in the left internal thoracic artery - left anterior descending artery, ao-saphenous vein graft - d, ao- saphenous veing graft to the atrioventricular branch.There was no bleeding noticed in the in the coronary artery that needs hemostasis.Later on, cag was re-examined.The atrioventricular branch was observed with a pseudoaneurysm.An intervention was done as a non-bsc guiding catheter was engaged in the rca, and delivered a coil and placed on the covered stent.Also, a non -bsc guidewire was advanced and to deliver a covered stent while performing coaxial technique with a balloon.However, it was blocked due to calcification and was unable to advanced beyond the rca distal.The calcification was treated with a rotablator and the size was changed to a bigger size from 1.5mm to 2.0mm in order to advance the stent in the av branch and to place the covered stent before reaching the bifurcation in the av branch.It was confirmed that blood flow to the pseudoaneurysm had disappeared by the final imaging and eventually resulted in complete revascularization.No further patient complications were reported.

Manufacturer Narrative

Date of event is an estimated date based off the aware date as the exact event date was not reported.

Event Description

It was reported that pseudoanuerysm from coronary perforation occurred.The 99% stenosed target lesion area was located in the severely calcified mid right coronary artery (rca).The rca was considered to be the responsible lesion since the contrast delay was observed here during cag.A 1.50mm rotalink plus and a 330cm rotawire were used in a percutaneous coronary intervention (pci).During procedure, after the guidewire passed through, poba was performed from rca mid to the atrioventricular branch (av branch).Unfortunately, imaging device only managed to cross up to the rca mid and it was decided to perform rotablation.Rota wire floppy then replaced the guidewire and ablation was performed using a 1.50mm burr from rca mid to av branch, however perforation of the coronary artery occured due to a tortuous area during movement from the dista rca to the av branch.Hemostasis was carried out after poba at the affected area, an intra aortic balloon pump (iabp) was placed.The groin/inguinal area was punctured to gain vascular access for the covered stent to be advanced, and used a double guide method.The covered stent was then advanced by balloon that traps the guidewire but advancement was unsuccessful.Subsequently, it was noted that cardiac fluid did not increase and decrease in the blood pressure that time.A coronary artery bypass was performed semi-urgently with iabp placed in the left internal thoracic artery - left anterior descending artery, ao-saphenous vein graft - d, ao- saphenous veing graft to the atrioventricular branch.There was no bleeding noticed in the in the coronary artery that needs hemostasis.Later on, cag was re-examined.The atrioventricular branch was observed with a pseudoaneurysm.An intervention was done as a non-bsc guiding catheter was engaged in the rca, and delivered a coil and placed on the covered stent.Also, a non -bsc guidewire was advanced and to deliver a covered stent while performing coaxial technique with a balloon.However, it was blocked due to calcification and was unable to advanced beyond the rca distal.The calcification was treated with a rotablator and the size was changed to a bigger size from 1.5mm to 2.0mm in order to advance the stent in the av branch and to place the covered stent before reaching the bifurcation in the av branch.It was confirmed that blood flow to the pseudoaneurysm had disappeared by the final imaging and eventually resulted in complete revascularization.No further patient complications were reported.It was further reported that the patient was stable post procedure.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8854984
• MDR Text Key: 153089458
• Report Number: 2134265-2019-09140
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 08/04/2019
• Supplement Dates FDA Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE- AL 1.0 SH; GUIDEWIRE- AL 1.0 SH; STENT- ST01; STENT- ST01; GUIDEWIRE- AL 1.0 SH; STENT- ST01
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR