MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH UNIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt - left) / premature ventricular contraction (pvc) ablation procedure (with retrograde access to the left ventricular outflow tract (lvot)) with an unknown smart touch unidirectional sf catheter and suffered cardiac tamponade (ct) requiring pericardiocentesis.It was reported that after the case, the patient suffered a pericardial effusion.It is unknown how the effusion was confirmed.The patient's blood pressure dropped post-procedure after the access site was closed.The exact type of catheter is unknown at this time.It was reported that it is a "sf catheter, no contact force" was used- curve unknown) and that the catheter was discarded.The physician¿s opinion on the cause of this adverse event was that it was due to the perforation of the posterior lvot.The patient is reported to be in stable condition.It is unknown if the patient required extended hospitalization because of the adverse event.A transseptal puncture was not performed.Prior to noting the ct, ablation was performed.There was no evidence of a steam pop.No error messages were observed on the biosense webster equipment during the procedure.Force catheter was not used for this procedure.The patient is hemodynamically stable at the time of the report.The effusion was discovered/noticed because of hypotension.Perforation is suspected.The procedure was already completed when the tamponade was noticed.Evidence of any effusion present before the procedure is unknown and intracardiac echocardiography (ice) imaging was not used.

• Brand Name: UNK_SMART TOUCH UNIDIRECTIONAL SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12292358
• MDR Text Key: 265556012
• Report Number: 2029046-2021-01303
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention