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

Catalog Number D128211

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.(b)(4).

Event Description

It was reported that a patient underwent a procedure for atrial fibrillation with a pentaray nav eco catheter where one of the splines was damaged.During the case, while trying to insert the catheter into the sheath, the catheter got stuck, damaging one of the splines.It was not known at the time if there were any exposed wires or braiding, but there was no damage noted to the electrodes.Additionally, no detachment of any catheter components was reported.The catheter was replaced, and the case was completed without patient consequence.This file was originally assessed as not mdr reportable, as no spline detachment or exposed wires were reported, and the potential that this could have caused or contributed to an adverse event is remote.On (b)(6) 2017, the bwi failure analysis lab found that the 5th spline cover was damaged with an exposed wire.This creates a potential risk for the patient, making this event mdr reportable.The awareness date for this complaint has been reset to (b)(6) 2017, the date of the reportable finding.

Manufacturer Narrative

It was reported that a patient underwent a procedure for atrial fibrillation with a pentaray nav eco catheter where one of the splines was damaged.The returned device was visually inspected, and one of the spine covers was found to be damaged with a wire exposed.The catheter outer diameter was measured, and was found within specifications.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.During the manufacturing process, all catheters are inspected for visual damage prior to packaging.On-line inspections and functional tests are in place to prevent catheters with this type of damage from leaving the facility.The customer complaint has been verified.Based on the available analysis finding results, the damage on the spine cover does not appear to be caused by any internal bwi processes, as there is evidence that the device was manufactured in accordance with documented specification and procedures.The damage could possibly be related to the manipulation of the catheter during the procedure.The instructions for use state that excessive force must not be applied to advance or withdraw the catheter through the guiding sheath when resistance is encountered.In addition, extra care should be taken while inserting, aspirating and manipulating the guiding sheath.Manufacturer¿s reference number: (b)(4).

• Brand Name: PENTARAY NAV
• 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 7028875
• MDR Text Key: 92996274
• Report Number: 2029046-2017-01146
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: (01)10846835012255(11)170523(17)200430(10)17681556L
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: D128211
• Device Lot Number: 17681556L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 11/16/2017
• Supplement Dates FDA Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2017
• 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