MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. SMARTABLATE¿ SYSTEM IRRIGATION PUMP; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMARTABLATE PUMP

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

Patient Problem Air Embolism (1697)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

Multiple attempts have been made to obtain clarification on which system was used during this procedure.However, no further information has been made available.Since there is no clarification, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.Since no serial number was provided, no device history record (dhr) review could be performed.Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient who underwent an ablation procedure with a smartablate¿ system irrigation pump developed air embolism.During the case, a thermocool® smart touch® sf bi-directional navigation catheter was used with an agilis sheath (non-bwi product) and drawing of air into the sheath resulted in air entry into the patient.No medical/surgical intervention was required.There is no information provided by the site regarding damage to the hemostatic valve.There was no evidence of leakage or damage to the thermocool® smart touch® sf bi-directional navigation catheter during the irrigation check.The product was replaced, and the procedure continued without further issues.No further information is available.For biosense webster inc., air embolism events should be reported under the irrigation pump and the sheath used during the procedure.In this case, the sheath used was a non-bwi product and the specific product information of the irrigation pump used during the case is not available; therefore, a a generic code for smartablate pump has been used to capture and report this event.

• Brand Name: SMARTABLATE¿ SYSTEM IRRIGATION PUMP
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8746744
• MDR Text Key: 149630081
• Report Number: 2029046-2019-03365
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/12/2019

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 Catalogue Number: UNK_SMARTABLATE PUMP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 06/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening