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

Model Number D-1266-01-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems ST Segment Elevation (2059); Injury (2348)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

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.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant medical products: carto 3 rmt system (model# m-5830-01 serial# (b)(4)); stockert 70 system (model# unknown serial# unknown); coolflow pump (model# unknown serial# unknown); soundstar catheter (model# m-5723-15, lot# unknown).Full udi # information unavailable since the lot number is unknown.(b)(4).

Event Description

It was reported that a (b)(6) female patient underwent an ablation procedure for idiopathic ventricular tachycardia with a navistar rmt thermocool electrophysiology catheter and suffered an st segment elevation requiring stent placement.During ablation, a left coronary vessel spasm was noticed along with an st elevation (lead unknown) which was confirmed via angiography.The patient did require hospitalization as a result of this adverse event.The patient was reported to be in stable condition at the time the complaint was reported.Additional information was received on the event.No transseptal puncture had been performed.Overall ablation time at the site of injury was 30 seconds with one ablation total.Irrigated catheter flow was set at 30 ml/min.There were no error messages observed on any biosense webster equipment during the procedure.There were no claims of any biosense webster product malfunctions.Patient history includes premature ventricular contractions (pvcs) and cardiomyopathy.The physician's opinion regarding the cause of this adverse event is that it was related to patient condition.

• Brand Name: NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• 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: joaquin kurz ; 9497893837
• MDR Report Key: 5333336
• MDR Text Key: 34647542
• Report Number: 2029046-2015-00278
• 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
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1266-01-S
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: UNKNOWN_D-1266-01-S
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention
• Patient Age: 79 YR