MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SF BI-DIRECTIONAL CATHETER

Model Number D-1314-00

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

Patient Problem Nerve Damage (1979)

Event Date 05/31/2017

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.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Concomitant products that used in this study: carto.Other companies devices that used in this study: cardiac stimulator bc-1100, flexability, fantasista, arctic front advance.(b)(4).The device is not returned to bwi.

Event Description

This complaint is from a literature source.It was reported that 108 patients with paroxysmal af or short-lasting persistent af underwent svc isolation or pvi isolation.Among them, phrenic nerve injury occurred in 1 conventional group patient which recovered 1 month later.Based on the facts of the case and the author¿s assessment, there were no reported malfunction with any of the bwi catheters and systems used during the case.Thus, this event is unrelated to the device and most likely related to the procedure.Title: ¿electrical superior vena cava isolation using a novel pace-and-ablate technique under diaphragmatic electromyography monitoring¿ the purpose of this study was to evaluate the feasibility of a novel superior vena cava isolation (svci) technique using simultaneous pacing and ablation through the tip of a single mapping/ablation catheter.A 28-mm second-generation cryoballoon (arctic front advance, medtronic) and an irrigated-tip catheter (flexability, st.Jude medical, or surround flow, biosense webster) were used in the study.The article did not state which device the patients used suffered adverse events.Bwi takes conservative approach to report this event under thermocool sf catheter.

• Brand Name: THERMOCOOL® SF BI-DIRECTIONAL CATHETER
• Type of Device: THERMOCOOL® SF BI-DIRECTIONAL CATHETER
• 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: 6675374
• MDR Text Key: 78661740
• Report Number: 9673241-2017-00536
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2017

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 Model Number: D-1314-00
• Device Catalogue Number: D131400
• Device Lot Number: UNKNOWN_D-1314-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR