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

Model Number D-1282-07-S

Device Problem Insufficient Information (3190)

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

Event Date 07/20/2016

Event Type  Injury  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products: st.Jude medical brk-1 xs transseptal needle.St.Jude medical sl1 8.5fr sheath.(b)(4).Are related to the same incident.

Event Description

It was reported that a female patient underwent an ablation procedure for atrial fibrillation with a pentaray nav eco catheter and suffered a cardiac tamponade requiring pericardiocentesis.After 2 transseptal punctures, the patient became hypotensive.Tamponade was confirmed via intracardiac echocardiogram.Pericardiocentesis yielded 250cc.Patient was reported to be in stable condition at the time of complaint report.Patient did not require extended hospitalization as a result of this adverse event.Patient fully recovered.There were no patient factors cited that may have contributed to the adverse event.It was noted that the physician usually performs one transseptal puncture, but in this case he performed two.Physician's opinion regarding the cause of the adverse event is that the injury occurred with the second transseptal puncture and was not caused by any bwi product.Generator parameters were not reported, as no ablation had been performed.Patient received anticoagulant during the procedure with activated clotting times maintained in an unknown range.It was confirmed that the smarttouch catheter did not enter the patient铠body.It was noted that the adverse event was not caused by any bwi product.

Manufacturer Narrative

(b)(4).It was reported that a female patient underwent an ablation procedure for atrial fibrillation with a pentaray nav eco catheter and suffered a cardiac tamponade requiring pericardiocentesis.Upon receipt, the catheter was visually inspected and was found in good condition.The catheter was evaluated for eeprom, carto 3 and sensor functionality.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates that the catheter was properly calibrated during manufacturing.A deflection test was performed, which the catheter passed.The catheter was then tested for electrical performance and was found within specifications.Finally an, irrigation test was performed, and the catheter failed.Further investigation revealed that the irrigation tubing was bent at the tip area.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The catheter failed during the irrigation test, but the root cause of the cardiac tamponade remains unknown.The instructions for use state that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• 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: 5952666
• MDR Text Key: 54796342
• Report Number: 9673241-2016-00594
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• 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,Followup
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: D-1282-07-S
• Device Catalogue Number: D128207
• Device Lot Number: 17472936L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2016
• 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): Life Threatening; Required Intervention