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

Model Number D134805

Device Problem Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Since no device has been received for analysis, 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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient with tetralogy of fallot underwent a idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a medical device entrapment occurred requiring surgical intervention.During the procedure while mapping, the thermocool® smart touch® sf bi-directional navigation catheter became entrapped in the melody valve.With the help of interventional pediatric doctors, the physician tried for about 6 hours to get the catheter out of the valve.They tried with different sheaths but could not retrieve the catheter.The original sheath in use was a st.Jude agilis sheath.The patient remained stable throughout the procedure; no adverse events were reported.The physician proceeded with cardiac surgery the next day, and the patient had to have open heart surgery.In the operating room, the patient was intubated, and the melody valve was replaced.The patient also received cryoablation but experienced a lot of bleeding.Prolonged hospitalization was required, the patient has been intubated for a week.Physician¿s opinion regarding the cause of the event is that it was procedure related as the patient had a melody valve and the catheter went inside of it.The bleeding experienced will not be coded as it occurred while applying cryoablation and has no relationship to the biosense webster, inc.Ablation catheter.Per product instructions for use (ifu), ¿do not use this product in patients with prosthetic valves as the catheter may damage the prosthesis.¿ the described medical device entrapment was assessed as a reportable mdr malfunction.Since surgical intervention was required to prevent permanent impairment of a body function or permanent damage to a body structure, then the event it is to be considered serious and mdr-reportable.

Manufacturer Narrative

Additional clarification was received on june 16, 2020.The patient was a ¿pediatric¿ patient with the pediatric electrophysiologist because he had a congenital disorder, but he was 27 years old.The patient has been followed by this physician for some time.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: 10156464
• MDR Text Key: 197578866
• Report Number: 2029046-2020-00701
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 06/16/2020
• Supplement Dates FDA Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON BWI -ST. JUDE AGILIS SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 91