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 Device Displays Incorrect Message (2591)

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

Event Date 04/24/2017

Event Type  Injury  

Manufacturer Narrative

Event description continuation: information regarding generator settings at the time of injury.There is no information regarding power titration.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 was set at 8ml/min.Patient received anticoagulant during the procedure with activated clotting times maintained between 250-300 seconds.Errors included ¿error 20¿ on pole a and ¿stimulation routing disabled.¿ catheter was zeroed after the initial warm-up phase post catheter connection to the carto® 3 patient interface unit.Carto® 3 system did not indicate to re-zero the catheter.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.Multiple attempts have been made to obtain clarification on the biosense webster, inc.Catheters used during the procedure.However, no further information has been made available.With the information available, we are reporting this event under the pentaray navigational eco catheter.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) for the lot number 17645545l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant products: non biosense webster, inc.- st.Jude medical brk-1 xs curve (adult) transseptal needle.Non biosense webster, inc.- st.Jude medical 8 french sl0 sheath.(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an ablation procedure for atrial fibrillation with a pentaray navigational eco catheter and suffered a cardiac tamponade requiring surgical intervention.When the pentaray navigational eco catheter was connected to the patient interface unit (piu), a catheter sensor error (error 20 on pole a) appeared and the led 'ecg out' turned red.The cable and dongle were replaced and the issue persisted.The pentaray navigational eco catheter was replaced with another catheter and the issue resolved.One hour post catheter replacement, the patient became hypotensive and a tamponade was confirmed via transesophageal ultrasound.Pericardiocentesis yielded an unspecified amount of fluid.Remainder of procedure was aborted.Patient was transferred to the operating room for surgical repair of the right atrium.Patient required extended hospitalization as a result of the adverse event.Patient fully recovered.There were no factors cited that may have contributed to the adverse event.It was noted that the catheter sensor error was not related to the adverse event, the adverse event was not caused by the biosense webster, inc.Catheter, and no biosense webster, inc.Products were used at the site of injury.Physician¿s opinion regarding the cause of the adverse event is that the tamponade likely occurred during transseptal puncture.Transseptal puncture was performed with a st.Jude medical brk-1 xs curve (adult) transseptal needle.Sheath used was a st.Jude medical 8 french sl0.Generator parameters included power control mode with thermocool sf cut-off values and temperature cut-off of 40 degrees celsius.

Manufacturer Narrative

Additional information received on may 22, 2017 providing the following concomitant products: smart touch unidirectional sf catheter, model #: d-1347-02-s, lot #: 17613736l.C3 eco interface cable, model #: d-1344-01-s, lot: 17632064l.The assessment has been made to also report this event under this related smart touch unidirectional sf catheter (b)(4).Also, additional information was received on the event on may 29, 2017.The pacing leads were connected to the carto 3 patient interface unit¿s primary pacing port.The carto 3 system did not allow pacing during ablation.It was planned pacing that was to be performed.There was no unwanted pacing delivered.The micropace eps320 stimulator was being used during the procedure.(b)(4).

Manufacturer Narrative

Additional information was received on may 22, 2017.A secondary pentaray navigational eco catheter was also used in the procedure.Concomitant product: pentaray navigational eco catheter, model #: d-1282-08-s, lot #: 17630162l.(b)(4).

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 7/14/2017.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.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a (b)(6) male patient underwent an ablation procedure for atrial fibrillation with a pentaray navigational eco catheter.When the pentaray navigational eco catheter was connected to the patient interface unit (piu), a catheter sensor error (error 20 on pole a) appeared and the led 'ecg out' turned red.The cable and dongle were replaced and the issue persisted.The pentaray navigational eco catheter was replaced with another catheter and the issue resolved.One hour post catheter replacement, the patient became hypotensive and a tamponade was confirmed via transesophageal ultrasound.Pericardiocentesis yielded an unspecified amount of fluid.Remainder of procedure was aborted.Patient was transferred to the operating room for surgical repair of the right atrium.Patient required extended hospitalization as a result of the adverse event.Patient fully recovered.Errors included ¿error 20¿ on pole a and ¿stimulation routing disabled¿.The returned device was visually inspected and it was found in normal conditions.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 the catheter was properly calibrated during manufacturing.Additionally, a deflection and an irrigation test were performed and the catheter passed the tests.The returned device was then evaluated for electrical resistance and current leakage and it failed on electrode # 17.Further examination revealed that the lead wire # 17 was broken causing the improper signal condition.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 customer complaint cannot be verified.The root cause of the wire breakage cannot be determined.The root cause of the cardiac tamponade remains unknown.The instructions for use (ifu) states 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: 6583516
• MDR Text Key: 75718023
• Report Number: 9673241-2017-00385
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/25/2017

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: 01/31/2020
• Device Model Number: D-1282-08-S
• Device Catalogue Number: D128208
• Device Lot Number: 17645545L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/22/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/24/2017; 04/24/2017
• Supplement Dates FDA Received: 06/15/2017; 06/20/2017; 07/17/2017; 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 98