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 Death (1802); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 11/05/2020

Event Type  Death  

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 Description

It was reported that a intellamap orion high resolution mapping catheter was used in a cryo pulmonary vein isolation (pvi) procedure.During the procedure initial mapping and therapy delivery with a non-boston scientific cryo-ablation system were completed without difficulty.During post validation mapping, the orion revealed a gap in the left superior pulmonary vein (lspv) that required additional cryo therapy.The additional therapy was again completed without difficulty.During the post procedure ep study, the patient became hypotensive and a pericardial effusion was identified.Pericardiocentesis was performed and a thoracotomy, a laceration was identified at posterior left atrium (la) at junction to the lspv near the location identified for repeat therapy.The patient did not recover and the death was called after approximately 2 hours.The physician has stated that she did not feel any abnormal resistance to movement while using/deploying the orion at any point during the procedure.

• 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 CORPORATION; 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: 10937063
• MDR Text Key: 219287026
• Report Number: 2134265-2020-16829
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2020

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 Expiration Date: 03/12/2022
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0025996929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death