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

Model Number D-1282-08-S

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

Patient Problems Air Embolism (1697); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a (b)(6) female patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation with a pentaray nav eco catheter and suffered a suspected air embolism requiring medication for blood pressure support, sonography, and angiography.Transseptal puncture was performed.Pentaray nav eco catheter was flushed and inserted into the left atrium.As mapping was about to be initiated, the patient became severely hypotensive and bradycardic.Patient was stabilized with medication for blood pressure support.Sonography and coronary angiography were performed and did not provide confirmation of air embolism.Patient was noted to be in atrial fibrillation.After stabilization, mapping and pvi were performed.Atrial fibrillation was successfully terminated.Patient did not require extended hospitalization as a result of the adverse event.Patient fully recovered with no residual effects.Procedure was prolonged by 20 minutes.Physician did not attribute the event to a bwi product, but to transseptal puncture.The medical rationale that indicates that the bwi product was in no way related to the adverse event is that air was introduced into the left atrium during transseptal puncture.Physician¿s opinion regarding the cause of the adverse event is that it was related to procedure, specifically transseptal puncture.However, this complaint is being conservatively reported because the patients symptoms occurred after insertion of this catheter into the body and no air embolism was ever confirmed.

• Brand Name: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6601119
• MDR Text Key: 76303522
• Report Number: 9673241-2017-00418
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K123837
• 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: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: D-1282-08-S
• Device Catalogue Number: D128208
• Device Lot Number: 17649112L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2017
• 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): Life Threatening
• Patient Age: 57 YR
• Patient Weight: 53