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

Model Number	1865
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2020 as the correct/exact date was not provided.Initial reporter address: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred via facility medwatch # (b)(4).The patient had recently demonstrated to have critical multivessel disease with loss of all grafts including left internal mammary artery (lima) to left anterior descending artery (lad).Percutaneous coronary intervention (pci) was recently performed to lad, and circumflex artery.Pci was also performed two days before to the patient's right coronary artery (rca).An 8 french guide catheter, j wire, samurai and 6 french guidezilla was advanced into the ascending aorta, and engaged the target lesion located in the right coronary artery (rca) with 1.25mm and a 1.2mm x 12mm threader balloon catheter.However, during inflation at 16-18 atmospheres, the balloon ruptured.The balloon was replaced with a 2.5x15mm compliant balloon, which successfully dilated the lesion.The guidezilla was utilized to support and placed a 3.5x38 non bsc stent and post-dilated with a 3.75x20mm non-compliant balloon.A focal dissection was expected due to deep engagement and guidezilla utilization.A 3.5x20mm non bsc stent was implanted, and post-dilation was performed at 20 atmospheres.All devices were removed from the patient's body, and the procedure was tolerated hemodynamically.There were no further complications reported.

• Brand Name: THREADER
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10593518
• Report Number: 2134265-2020-13380
• Device Sequence Number: 19766901
• Product Code: LOX
• UDI-Device Identifier: 08714729848134
• UDI-Public: 08714729848134
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K134031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2022
• Device Model Number: 1865
• Device Catalogue Number: 1865
• Device Lot Number: 0025229502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 8FR AL1; GUIDE EXTENSION: 6FR GUIDEZILLA; GUIDEWIRE: J WIRE, LONG WIRE SAMURAI
• Patient Age: 81 YR
• Patient Weight: 91