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

Model Number D-1282-11-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 02/11/2016

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 products: carto 3 system (model# m-4800-01 serial# (b)(4)), smarttouch (model# d-1327-04-s lot# unknown) ¿ not used in patient, smartabalte generator (model# m-4900-07 serial# (b)(4)).(b)(4).

Event Description

It was reported that a male patient, approximately (b)(6), underwent an ablation procedure for atrial fibrillation with a pentaray nav eco high-density mapping catheter and suffered a cardiac tamponade requiring pericardiocentesis.At the end of cryoablation (with non-biosense webster product), the patient became hypotensive and a pericardial effusion was confirmed via intracardiac echocardiogram.The effusion was noticed following the last freeze of the last vein.A pericardiocentesis was performed which yielded 1 liter of fluid.The patient also required blood a transfusion.Patient was reported to be in stable condition at the time this event was reported.The patient required overnight stay due to blood transfusion of approximately 3-4 units.The bleeding resolved and the patient was transferred to the intensive care unit.The patient outcome has improved.Medical history includes recurrent atrial fibrillation with a previously failed ablation procedure that involved another pericardial effusion.The physician's opinion regarding cause of adverse event is that it was related to patient's genetically thin cardiac walls and genetic predisposition to perforations (patient-related) and possibly caused by pushing a sheath (non-biosense webster product) too far into left atrium (procedure-related).A transseptal puncture was performed with a st.Jude medical brk needle.The patient received anticoagulation during the procedure which was reportedly maintained at clinically acceptable values.Overall radiofrequency ablation time at site of injury was zero minutes.Cryoablation time (with non-biosense webster product) was 24 minutes in the left atrium.Biosense webster radiofrequency ablation catheter never entered patient's body; however mapping was performed prior to injury with the pentaray catheter.Therefore, this event is conservatively being reported under the pentaray catheter because it was used in the patient prior to the injury.

• 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 ; 9497893837
• MDR Report Key: 5492189
• MDR Text Key: 40068616
• Report Number: 9673241-2016-00179
• 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: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1282-11-S
• Device Catalogue Number: D128211
• Device Lot Number: UNKNOWN_D-1282-11-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• 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
• Patient Age: 70 YR