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

Catalog Number UNK_PENTARAY NAV ECO

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

Patient Problem Cardiac Tamponade (2226)

Event Date 05/27/2020

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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a male patient (b)(6) kg) underwent paroxysmal atrial fibrillation (afib) procedure with pentaray nav high-density mapping eco catheter and suffered cardiac tamponade requiring pericardiocentesis.During the mapping phase, a pericardial effusion was diagnosed via (ice) intracardiac electrocardiogram.A pericardiocentesis was performed by the physician.The amount of fluid removed was not provided.The caller stated that the physician thought the effusion was caused by the sheath (medtronic flex cath sheath) when going transseptal.The patient was stable at the time of the call.This event occurred after the use of the pentaray catheter.The patient¿s condition has improved.They were still at the hospital at the time of the additional information was provided (b)(6) 2020) but were in good condition.Recovery from pericardiocentesis will likely result in longer stay.Transseptal puncture performed with medtronic flex cath sheath and baylis nrg needle.No ablation was performed prior to effusion and thus there was no evidence of steam pop.The irrigation was on low setting.There were no error messages observed on biosense webster equipment during the procedure.Since the pentaray nav high-density mapping eco catheter was in use, we cannot exclude it and therefore are conservatively reporting this event under the pentaray nav high-density mapping eco catheter.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 10177241
• MDR Text Key: 196434496
• Report Number: 2029046-2020-00737
• Device Sequence Number: 1
• Product Code: MTD
• 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: Physician
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_PENTARAY NAV ECO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 95