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

Model Number D-1197-17-S

Device Problems Inability to Irrigate (1337); Occlusion Within Device (1423); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

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.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.Manufacturer's ref.No:(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a navistar® thermocool® electrophysiology catheter and foreign material was on the catheter tip.There was no irrigation coming out from the catheter and there was a small balloon surrounding the holes and that filled with saline preventing the irrigation.The catheter was changed in order to continue the procedure.There was 15 minute delay to get another catheter.The patient was under general anesthesia and a transseptal puncture had been performed.The procedure was complete with no patient consequence.The physician did not consider the delay may have caused or contributed to a death or a serious injury to the patient.There were no errors on the pump.The irrigation issue is not mdr reportable because occlusion or no irrigation is highly detectable by the physician.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event is remote.However, if foreign material is found adhered to the catheter within the usable length during or after the procedure, including plastic or other elements, then it poses patient risk such as embolism.Therefore this complaint is mdr reportable.

• Brand Name: NAVISTAR® THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 6215601
• MDR Text Key: 63840863
• Report Number: 9673241-2016-00929
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000566
• UDI-Public: (01)10846835000566(11)141018(17)170930(10)17116172M
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P030031
• 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
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: D-1197-17-S
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 17116172M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2014
• 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