MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGENT; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 3825

Device Problem Defective Device (2588)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/08/2021

Event Type  Injury  

Event Description

It was reported that incorrect length of a balloon and obstruction occurred.A percutaneous coronary intervention (pci) was performed on the obtuse marginal 1 (om1).A wolverine cutting balloon was chosen for first intervention on om1.The wolverine was positioned within the lesion using the 2 radiopaque markers as reference.The cutting balloon was inflated slowly to 15 atmospheres for 20 seconds.The wolverine was removed from the patient.Following removal of the wolverine from the patient body, glyceryl trinitrate (gtn) 100mcg was given.The next intervention was to drug eluting balloon (deb).A 2.75mm x 15mm agent dcb balloon was advanced and inflated for 18 atmospheres for 47 seconds at the same lesion.Upon examination of cine, balloon overhang was noticed.The deb was removed and gtn 100mcg was given.The cines from the post intervention showed that the other branch got pinched.The procedure was completed.No patient complications were reported in relation to this event and the patient was stable following the procedure.

Event Description

It was reported that incorrect length of a balloon and obstruction occurred.A percutaneous coronary intervention (pci) was performed on the obtuse marginal 1 (om1).A wolverine cutting balloon was chosen for first intervention on om1.The wolverine was positioned within the lesion using the 2 radiopaque markers as reference.The cutting balloon was inflated slowly to 15 atmospheres for 20 seconds.The wolverine was removed from the patient.Following removal of the wolverine from the patient body, glyceryl trinitrate (gtn) 100mcg was given.The next intervention was to drug eluting balloon (deb).A 2.75mm x 15mm agent dcb balloon was advanced and inflated for 18 atmospheres for 47 seconds at the same lesion.Upon examination of cine, balloon overhang was noticed after the use of the agent balloon.The deb was removed and gtn 100mcg was given.The cines from the post intervention showed that the other branch got pinched/narrowed.The procedure was completed.No patient complications were reported in relation to this event and the patient was stable following the procedure.It was further reported that the balloon was not being used inside a previously placed stent.The lesion was 85% stenosed with mild tortuosity and mild calcification.The other branch that was pinched/narrowed was the circumflex coronary artery.There were no patient issues related to the vessel being pinched.

Event Description

It was reported that incorrect length of a balloon and obstruction occurred.A percutaneous coronary intervention (pci) was performed on the obtuse marginal 1 (om1).A wolverine cutting balloon was chosen for first intervention on om1.The wolverine was positioned within the lesion using the 2 radiopaque markers as reference.The cutting balloon was inflated slowly to 15 atmospheres for 20 seconds.The wolverine was removed from the patient.Following removal of the wolverine from the patient body, glyceryl trinitrate (gtn) 100mcg was given.The next intervention was to drug eluting balloon (deb).A 2.75mm x 15mm agent dcb balloon was advanced and inflated for 18 atmospheres for 47 seconds at the same lesion.Upon examination of cine, balloon overhang was noticed after the use of the agent balloon.The deb was removed and gtn 100mcg was given.The cines from the post intervention showed that the other branch got pinched/narrowed.The procedure was completed.No patient complications were reported in relation to this event and the patient was stable following the procedure.It was further reported that the balloon was not being used inside a previously placed stent.The lesion was 85% stenosed with mild tortuosity and mild calcification.The other branch that was pinched/narrowed was the circumflex coronary artery.There were no patient issues related to the vessel being pinched.

Manufacturer Narrative

The returned product consisted of an agent (dcb) balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.The device was soaked in a water bath for an hour to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The marker bands measured at 15mm from distal to proximal ends while inflated and deflated.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported incorrect length.

• Brand Name: AGENT
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11168398
• MDR Text Key: 226775913
• Report Number: 2134265-2021-00291
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2021
• Device Model Number: 3825
• Device Catalogue Number: 3825
• Device Lot Number: 14165H19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/19/2021; 03/04/2021
• Supplement Dates FDA Received: 02/09/2021; 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other