MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D-1282-08-S

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

Patient Problems Hemorrhage/Bleeding (1888); Cardiac Perforation (2513)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant medical products: carto 3 system (model# m-4800-01 serial# (b)(4)); smartablate generator (model# m-4900-07 serial# (b)(4)); smart ablate pump (model# m-4900-08 serial# (b)(4)); smarttouch bidirectional sf catheter (model# d-1348-04-s lot# unknown); c3 ez steer cs with auto id catheter (model# d-1263-06-s lot# unknown); soundstar eco catheter (model# m-5723-16 lot# unknown); st.Jude medical brk-1 xs transseptal needle (model# unknown lot# unknown); st.Jude medical 8.5 french sl1 (model# unknown lot# unknown).(b)(4).

Event Description

It was reported that a male patient underwent an ablation procedure for persistent atrial fibrillation with a pentaray nav eco catheter and suffered a cardiac perforation requiring surgical intervention.During mapping phase, the pentaray catheter was placed in the left atrial appendage (laa), which caused a perforation.The result was an abdominal bleed which required the patient to have surgical repair of the laa.Patient was reported to be in stable condition in the intensive care unit.Patient required extended hospitalization as a result of the adverse event for surgical recovery.Patient outcome is improved.Cardiovascular medical history includes a previous pericardiectomy and a convergent atrial fibrillation procedure.There were no factors cited that may have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that the advancement of the pentaray nav eco catheter while in the laa resulted in the perforation.Transseptal puncture was performed with a st.Jude medical brk-1 xs transseptal needle.Sheath used was a st.Jude medical 8.5 french sl1.Generator parameters and settings at the time of injury were not reported, as ablation was not being performed at the time of injury.Overall ablation time and last ablation cycle time at the site of injury were not reported, as no ablation was performed at the site of injury.Irrigated catheter flow setting was not reported.Patient received anticoagulant during the procedure with activated clotting time maintained between 300-350 seconds.It was noted that no errors appeared on the carto 3 system.

• Brand Name: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6595227
• MDR Text Key: 76127673
• Report Number: 9673241-2017-00413
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1282-08-S
• Device Catalogue Number: D128208
• Device Lot Number: UNKNOWN_D-1282-08-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention