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

Model Number	H7493927012120
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Incident description: balloon was inflated in calcific lesion to dilate right coronary vessel, balloon burst at 16-18atm during inflation.Indications: high-grade crescendo angina.Markedly abnormal functional study.Recent cardiac catheterization with occlusion of all bypass grafts including her left internal mammary artery (lima) to the left anterior descending (lad) artery and graft to the circumflex and right coronary artery.Status post lad and circumflex drug-eluting stent (des) and percutaneous coronary intervention (pci) 2 days previously.Residual extremely high-grade ulcerated stenosis in the midportion of the rca.Plan: this patient had recently demonstrated to have critical multivessel disease with loss of all grafts including her lima to the lad.She is status post recent des pci to the lad and circumflex system and as described above, attempted intervention days previously to her right coronary artery (rca) and despite aggressive manipulations of the vessel was unable to deliver balloons across the index lesion.Rca intervention was deferred at the time, but the vessel clearly had been aggressively manipulated.Notes from the procedure: "at this point, an 8-french al1 guiding catheter was advanced over a j wire into the ascending aorta and engaged the rca.I crossed with a samurai long wire.A 6-french guidezilla was also utilized.I was able to cross with a 1.25 mm with a 1.2x12 mm spreader over the wire balloon.I exchanged for a mailman wire and then was able to balloon dilate with the spreader balloon with a rupture of the balloon.I then was able to pass a rapid exchange 2.5x15 mm compliant balloon, which allowed for initial dilatation of the index lesion.After this, in utilizing the support of the guidezilla, i was able to pass a 3.5x38 mm xience alpine sierra across the entire diseased segment.This was then postdilated with a 3.75x20 mm noncompliant balloon.With deep guide engagement and guidezilla utilization, there was an expected focal dissection of the proximal vessel, which was then stented with a 3.5x20 mm xience alpine sierra drug-eluting prosthesis.Post-dilatation was performed with a 3.75 mm balloon taken to 20 atmospheres.At this point, all catheters and wires were removed from the body.This was all tolerated hemodynamically." there were no complications."uncomplicated complex drug-eluting stent and percutaneous coronary intervention to the proximal mid right coronary artery with an excellent result in the setting of a high-grade ulcerated stenosis in a large and super-dominant vessel.".

• Brand Name: THREADER
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10507065
• Report Number: 10507065
• Device Sequence Number: 19533943
• Product Code: LOX
• UDI-Device Identifier: 08714729848134
• UDI-Public: (01)08714729848134(17)220218(10)25229502
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/08/2020
• Report Date (Section F): 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493927012120
• Device Lot Number: 25229502
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 91
• Date Report Sent to FDA: 09/08/2020