MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; CARDIAC ABLATION PERCUTANEOUS CATHETER

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

Patient Problem Embolism (1829)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.Event date is unknown so event was approximated.

Event Description

It was reported that patients were experiencing asymptomatic cerebral infarction.In this facility, all patients before and after an ablation undergo a head magnetic resonance imaging (mri).Patients who used rhythmia had a significantly higher rate (approximately 40%) of asymptomatic cerebral infarction.Prior preparation and reflux of the intellamap orion high resolution mapping catheter, insertion in to the sheath and such were being paid attention for, and the usage method was also appropriate, but it came up with this result.At present, no symptomatic infarction has been confirmed.The physician was to follow-up with patients.It was further reported that a boston scientific ablation catheter was also used during the procedure.The model and lot number were unknown.

• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora,; heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9193463
• MDR Text Key: 162365888
• Report Number: 2134265-2019-12505
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• 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: 09/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Patient Outcome(s): Other