MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Ischemia Stroke (4418)

Event Date 12/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30441644m number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cerebral infarction (cerebrovascular accident (cva)) requiring follow up in the intensive care unit (icu).No bwi product malfunctions nor immediate patient consequences from the procedure were reported.Post-procedure, it was reported the patient had difficulty on moving its limbs.Magnetic resonance imaging (mri) was taken, and cva was confirmed.Patient was sent to the icu for follow up.There¿s no information on the type of treatment provided.There¿s no indication that prolonged hospitalization was required.Patient¿s outcome is unknown.Physician commented the cause of the adverse event is unknown; however, does not believe it was derived from the bwi product.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information available, this is being conservatively coded under the ablation catheter.Since the event is life threatening and might result in permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 2/18/2021, bwi received additional information indicating that the patient is male.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11199606
• MDR Text Key: 227742091
• Report Number: 2029046-2021-00063
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/24/2020

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 Expiration Date: 09/20/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30441644M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/24/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; HALO; LASSO NAV; PENTARAY NAV; SOUNDSTAR ECO; VIZIGO SHEATH; CARTO 3 SYSTEM; HALO; LASSO NAV; PENTARAY NAV; SOUNDSTAR ECO; VIZIGO SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention