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 Occlusion Within Device (1423)

Patient Problem ST Segment Elevation (2059)

Event Date 11/24/2016

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Lot #17487617l.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a pentaray nav eco catheter and suffered a transient st segment elevation requiring no medical or surgical intervention.Mapping with the pentaray was completed.After the first episode of ablation, a transient st segment elevation was observed on the diii (inferior) surface lead.No intervention was administered.It was also reported that during the procedure, a not reportable irrigation issue was observed.Catheter was replaced and the issue was resolved.It was noted that the physician became aware of the irrigation issue once the catheter was out of the patient and that the source of the issue was unknown.It was also noted that it is uncertain if the st segment elevation was related to the irrigation occlusion issue and that it may have been related to ablation near the coronaries.Additional information was requested on this event.However, no further information has been made available.Since it was not confirmed if prolonged hospitalization was required for treatment or prevention of permanent damage to the patient, we will consider this mdr reportable.

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) for the lot number 17487617l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

The manufactured date and expiration date have been provided.Therefore, expiration date and manufactured date have been populated.(b)(4).

• 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: 6201554
• MDR Text Key: 63187521
• Report Number: 9673241-2016-00892
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: D-1282-08-S
• Device Catalogue Number: D128208
• Device Lot Number: 17487617L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other