MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR® THERMOCOOL®; SIMILAR DEVICE NI75TCJH, PMA # P030031

Model Number D-1197-00

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

Patient Problem Ischemia (1942)

Event Date 12/31/2010

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.Since the lot number is unknown, the full udi number cannot be provided.Concomitant products were used during this study: lasso circular mapping catheter; carto 3 mapping system.Other company¿s devices were used during this study: 1.5 t scanner (1.5 tesla magnetom avanto, siemens), 8f long sheath (fast-cath, st.Jude or swartz left 0, st.Jude-sl0).(b)(4).Methods: no testing methods performed.Results: no results available since no evaluation performed.Conclusion: device discarded by user, unable to follow-up.(b)(4).

Event Description

This complaint is from a literature source.It was reported that one patient with paroxysmal atrial fibrillation underwent cardiac ablation procedure.Post-procedural cerebral mri unveiled asymptomatic ischemic lesions.The lesion was localized in the right parietal cortex.The lesions dimension was 5mm.The neurological examination and carotid doppler was repeated just after the post ablation cerebral mri and it resulted negative.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: "impact of ablation catheter irrigation design on silent cerebral embolism after radiofrequency catheter ablation of atrial fibrillation: results from a pilot study." the purpose of this study was to compare procedural parameters and safety of pulmonary vein isolation (pvi) performed by using open-irrigated catheters with different irrigation design.The study was conducted between october 2010 and december 2010.Other adverse events were reported in this article: 1 patient one asymptomatic ischemic lesion (dimension 2mm) localized in the left occipital cortex; 1 patient two asymptomatic ischemic lesions (dimension 3 and 4 mm, respectively) localized in the left frontal cortex; 1 patient one asymptomatic ischemic lesion (dimension 6mm) localized right frontal cortex; 1 patient two asymptomatic ischemic lesions (dimension 3 and 7 mm, respectively) localized both in the left cerebellum.Suspected device is navistar thermocool ablation catheter, however catalog and lot number are unknown.

• Brand Name: NAVISTAR® THERMOCOOL®
• Type of Device: SIMILAR DEVICE NI75TCJH, PMA # P030031
• 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: shahe garabedian ; 9098397362
• MDR Report Key: 5009316
• MDR Text Key: 23220896
• Report Number: 2029046-2015-00214
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Report Date: 07/24/2015

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-1197-00
• Device Catalogue Number: D119700
• Device Lot Number: UNKNOWN_NAVISTAR THERMO TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• 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): Life Threatening
• Patient Age: 56 YR