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 Hematoma (1884); Rash (2033); Vascular Dissection (3160); Pericardial Effusion (3271); Heart Block (4444)

Event Date 04/26/2021

Event Type  Injury  

Event Description

It was reported that a journal article was received indicating a variety of patients underwent ultra-high-density mapping and radiofrequency ablation for supraventricular tachycardia between february 2017 and september 2020.Of the 85 procedures performed the following complications, each in one patient, occurred: cerebral embolic event with post-procedural diplopia and minimal sequela at last follow-up, small pericardial effusion, ventricular lead micro-dislodgement, periprocedural transient atrioventricular block, peri-procedural diffuse erythematous rash leading to loss of fidelity of previously constructed maps, retroperitoneal venous bleeding and arterial dissection.All complications resolved spontaneously without the need for intervention.Kahle ak, gallotti rg, alken fa, meyer c, moore jp.Electrophysiological characteristics of intra-atrial reentrant tachycardia in adult congenital heart disease: implications for catheter ablation.J am heart assoc.2021 jul 6;10(13):e020835.Doi: 10.1161/jaha.121.020835.Epub 2021 jun 14.

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.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• 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: 14518406
• MDR Text Key: 292788930
• Report Number: 2134265-2022-06068
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INTELLANAV MIFI OPEN-IRRIGATION CATHETER/ABLATION
• Patient Outcome(s): Other