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

Model Number D-1282-04-S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aortic Valve Stenosis (1717); Pain (1994); Aortic Dissection (2491)

Event Date 01/24/2014

Event Type  Injury  

Event Description

It was reported that after a non ischemic left sided vt procedure, the patient complained of back pain after the ablation procedure, aortic dissection was discovered on ct.The physician stated that the patient had aortic stenosis and felt that the tines of the pentaray catheter had got caught between the sheath and the aortic wall.The physician is not sure if that was the cause of the injury.The patient¿s status was unknown.

Manufacturer Narrative

The concomitant products: carto 3 system: serial # (b)(4); stockert generator: serial # (b)(4); cool flow pump: serial # (b)(4); tc sf catheter with d / f curve: cat# and lot # are unknown.(b)(4).

Manufacturer Narrative

Refer to evaluation summary (b)(4) it was reported that after a non ischemic left sided vt procedure it was found that the patient had developed an aortic dissection.Customer stated that the physician stated that the patient had aortic stenosis and felt that the tines of the pentaray catheter had got caught between the sheath and the aortic wall.The returned device was visually inspected upon receipt and shaft was bent with white stress marks about 7 cm and 14 cm from the transition of the lumen.These catheter shaft conditions were not reported by the customer.However, the damages could be related when the catheter got stuck.Then per the reported event, the catheter was tested for electrical performance and it was found within specifications.Furthermore, an irrigation test was performed and the catheter passed, no occlusion was observed.The catheter was also evaluated for eeprom, carto 3 and calibration 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.A deflection test was also performed and catheter passed.Catheter tines were checked and the rings were not squashed, pu (adhesive) was found normal and tines were straight and unbent.The catheter ods were also measured and catheter passed.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 passed all specifications.The root cause of the aortic dissection remains unknown.The ifu states that careful catheter manipulation must be performed in order to avoid cardiac damage.

• Brand Name: PENTARAY® NAV HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3632040
• MDR Text Key: 21490898
• Report Number: 2029046-2014-00045
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120425
• 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: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: D-1282-04-S
• Device Catalogue Number: D128204
• Device Lot Number: 15836400L
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2013
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other