MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CROSSBOSS; CATHETER, PERCUTANEOUS

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

Patient Problems Myocardial Infarction (1969); Perforation (2001); Cardiac Tamponade (2226); Vascular Dissection (3160)

Event Date 10/12/2018

Event Type  Injury  

Manufacturer Narrative

Zivelonghi, c, van kuijk, j.P., et al (2019).A "minimalistic hybrid algorithm" in coronary chronic total occlusion revascularization: procedural and clinical outcomes.Catheter cardiovasc interv.Volume 95, pages 97-104.Date of event was approximated using date of article submission.

Event Description

It was reported via journal article that serious injuries occurred.Percutaneous recanalization of coronary chronic total occlusions (ctos) data was reviewed for various techniques.In some approaches, stingray and crossboss devices were used.Two perforations were observed, one of which resulting in cardiac tamponade and requiring pericardiocentesis after successful recanalization of a mid-right coronary artery (rca), the other involving a septal branch and treated conservatively by balloon inflation in place and protamine administration with no hemodynamic consequences, after failed septo-septal ipsilateral crossing in a mid-left anterior descending artery (lad) occlusion.Of note, two donor-artery dissections, were observed during the procedure and treated with stent implantation.Three myocardial infarctions were also noted.At clinical follow-up, one myocardial infarction and three target vessel revascularizations were noted.

• Brand Name: CROSSBOSS
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10119680
• MDR Text Key: 194024431
• Report Number: 2134265-2020-07530
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention