MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 87035

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

Patient Problems Stroke/CVA (1770); 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 un known 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.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.Lot number was not provided; therefore, a ship history of previous lots sent to the customer was reviewed.Device history record (dhr) review of the lots identified found no issues.B3: event date is unknown so event was approximated.F10 patient code: corrected.

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 arrhythmia 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.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8961677
• MDR Text Key: 156774463
• Report Number: 2134265-2019-10659
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BOSTON SCIENTIFIC ABLATION CATHETER
• Patient Outcome(s): Other