MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number UNK_PENTARAY

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

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent left idiopathic ventricular tachycardia - left (l-idvt) ablation with pentaray nav high-density mapping catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.The event occurred during use of biosense webster, inc.Product.During an idiopathic left sided premature ventricular contraction (pvc) procedure, it was observed by ultrasound that the patient developed a pericardial effusion.A pericardiocentesis was performed in which 1600 cc's were removed from the pericardial space.The patient was transferred to the operating room for surgical repair.There was no information about the hospitalization.The physician stated that the splines of the pentaray nav high-density mapping catheter caused 2 holes in the heart.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since the physician provided a specific injury mechanism after surgical intervention, the event will be reported only under the pentaray nav high-density mapping catheter.

Manufacturer Narrative

Additional information was received on february 13, 2020 that the device was 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Initially, the physician stated that the splines of the pentaray nav high-density mapping catheter caused 2 holes in the heart.Since the physician provided a specific injury mechanism after surgical intervention, the event was reported under the pentaray nav high-density mapping catheter (g9: manufacturer report number.Additional information was received on april 7, 2020, stating the surgeon saw two openings and initially suggested that they were caused by the pentaray nav high-density mapping catheter.The electrophysiologist and the sales representative herself disagreed and two more experienced surgeons were consulted.They confirmed that based on the size and location of the perforations, one was caused by the ablation catheter ¿thermocool® smart touch® sf bi-directional navigation catheter¿ and the other by the unknown brand needle during the pericardiocentesis.The patient fully recovered and was discharged.Therefore, the event was reassessed as reportable under the thermocool® smart touch® sf bi-directional navigation catheter (g9: manufacturer report number: 2029046-2020-00571) and the pentaray nav high-density mapping catheter reportability was reassessed to not reportable as a concomitant product.The ¿d11: concomitant medical products and therapy dates¿ section was processed to reflect the ¿pentaray nav high-density mapping catheter¿ and the ¿unknown brand needle¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9714573
• MDR Text Key: 191683470
• Report Number: 2029046-2020-00248
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2020

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 Catalogue Number: UNK_PENTARAY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: 02/13/2020; 04/07/2020
• Supplement Dates FDA Received: 02/26/2020; 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF BID, TC, D-F; UNKNOWN BRAND NEEDLE; UNK_PENTARAY
• Patient Outcome(s): Life Threatening; Required Intervention