MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLAMAP ORION¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

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

Patient Problems Nausea (1970); Perforation (2001); Discomfort (2330); Malaise (2359); Pericardial Effusion (3271)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported a perforation occurred.During an ablation procedure to treat premature ventricular contractions (pvc), an intellamap orion¿ mapping catheter was advanced to the right ventricular outflow tract (rvot).It was noted when the catheter was delivered to the rvot using another manufacturer¿s introducer, ¿there was slight difficulty.¿ the patient stated she was ¿not feeling well,¿ therefore, the catheter was removed.The patient was conscious and seem to have no problem, but her blood pressure suddenly dropped.A perforation was confirmed with echo and the procedure was not completed due to the event.Percutaneous cardiopulmonary support (pcps) was on standby and ¿blood pressure had decreased due to drainage.¿ no further interventions were performed and the patient was in stable condition.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the patient also experienced pericardial effusion.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the ¿slight difficulty¿ delivering the catheter to the rvot referred to difficulty inserting the catheter.When the catheter entered the rvot, the patient felt uncomfortable and nauseated.The catheter was then removed from the rvot and symptoms improved.It was clarified that ¿drainage¿ was performed to address the event.

• Brand Name: INTELLAMAP ORION¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6816480
• MDR Text Key: 83477564
• Report Number: 2134265-2017-08250
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K122461
• 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,Followup,Followup
• Report Date: 08/02/2017

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: 03/15/2018
• Device Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Device Lot Number: 0020406716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 08/25/2017; 10/18/2017
• Supplement Dates FDA Received: 09/19/2017; 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTRODUCER: ST. JUDE MEDICAL AGILIS; MAPPING SYSTEM: BOSTON SCIENTIFIC RHYTHMIA
• Patient Outcome(s): Required Intervention