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

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

Patient Problems Death (1802); Hematoma (1884); Perforation of Vessels (2135); Obstruction/Occlusion (2422)

Event Date 10/12/2018

Event Type  Death  

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 a death occurred.Percutaneous recanalization of coronary chronic total occlusions (ctos) data was reviewed for various techniques.In some approaches, stingray and crossboss devices were used.A death occurred a few hours after a procedure in the mid-right coronary artery (rca).The cause of death was an ab extrinseco obstruction of the outflow tract of the right ventricle after perforation of a small side-branch of the proximal rca and consequent leakage with hematoma formation.At clinical follow-up, three all-cause deaths were documented.

• 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 MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10119227
• MDR Text Key: 194010786
• Report Number: 2134265-2020-07515
• 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): Death