MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1266-01-S

Device Problem Unintended Movement (3026)

Patient Problems Low Blood Pressure/ Hypotension (1914); Needle Stick/Puncture (2462); Pericardial Effusion (3271)

Event Date 02/24/2014

Event Type  Injury  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, the physician completed first transseptal and placed the rmt thermocool through the sl1 sheath into the left superior pulmonary vein (lspv).He then began the second transseptal which the needle went through the posterior aspect of the left atrium.The left atrium was punctured and the patient's blood pressure dropped.Ice confirmed a pericardial effusion.A pericardiocentesis was performed extracting 700 cc's of fluid and the patient stabilized.The patient was sent to observation.

Manufacturer Narrative

The concomitant products: carto 3 rmt (r10040); stockert (st-3921); coolflow pump (02125); stryer reprocessed soundstar.(b)(4).

Manufacturer Narrative

Refer to evaluation summary manufacturer ref # (b)(4).It was reported that during the second transeptal, the left atrium was punctured and the patient's blood pressure dropped.Ice confirmed a pericardial effusion.A pericardiocentesis was performed extracting 700 cc's of fluid and the patient stabilized.The returned device was visually inspected upon receipt and the inner section of the luber hub had some dark ¿ red material that appeared to be human blood.Per the event, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.Furthermore, a deflection test was performed and the catheter passed.The catheter was also evaluated for eeprom, carto 3, 4 khz 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.Finally, an irrigation test was performed and the catheter failed since three out of six irrigation ports were found occluded with dark ¿ red material, which appeared to be human blood.However, it remains unknown the origin of that material.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 the irrigation test, but the root cause of the pericardial effusion remains unknown.The ifu states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

Manufacturer Narrative

On march 14, 2014, upon receiving the product in biosense webster lab, it was noticed that inside luber hub connector irrigation tubing appears occluded.Investigation is still in progress.A supplemental report on device evaluation will be submitted.(b)(4).

• Brand Name: NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 3675584
• MDR Text Key: 4240270
• Report Number: 2029046-2014-00082
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• 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,Followup
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 16008802M
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention