MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; SIMILAR DEVICE D131501, PMA # P030031/S034

Model Number D-1315-00

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

Patient Problem No Information (3190)

Event Date 12/31/2014

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 were used during this study: carto, pentaray catheter, thermocool catheter.Other company¿s devices were used during this study: ensitetm navx (st.Jude medical inc), double transseptal brk needle (st.Jude medical inc).Manufacturer's ref.No: (b)(4).The device was not returned to bwi.

Event Description

This complaint is from a literature source.It was reported that 70 consecutive nonischemic patients underwent radiofrequency ablation and suffered major complication.No details of major complication were known.Additional information was received indicating that the author did not recall any related to specific malfunction of a device.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: ¿beyond the storm: comparison of clinical factors, arrhythmogenic substrate, and catheter ablation outcomes in structural heart disease patients with versus those without a history of ventricular tachycardia storm.¿ the purpose of this study was to compare the clinical factors, substrate, and outcomes differences in patients with sustained monomorphic vt who present for catheter ablation with vt storm versus those with a nonstorm presentation.The study was conducted between 1999 and 2014.Suspect device is thermocool sf catheter, however catalog and lot number are unknown.Concomitant products were used during this study: carto, pentaray catheter, thermocool catheter.Other company¿s devices were used during this study: ensitetm navx (st.Jude medical inc), double transseptal brk needle (st.Jude medical inc).

Manufacturer Narrative

(b)(4).

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Type of Device: SIMILAR DEVICE D131501, PMA # P030031/S034
• 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: 6201391
• MDR Text Key: 63188139
• Report Number: 9673241-2016-00882
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

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-1315-00
• Device Catalogue Number: D131500
• Device Lot Number: UNKNOWN_D-1315-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR