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

Model Number D-1282-07-S

Device Problems Collapse (1099); Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2015

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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a pentaray nav eco catheter and a mapping issue occurred as it was not possible to rebuild the fast anatomical map volume.The catheter was changed to another one and the procedure was completed with no patient consequence.This event was originally assessed as not reportable as the potential risk that it could cause or contribute to a serious injury or death is remote.Biosense webster failure analysis lab received the device for evaluation on september 4, 2015 and during visual inspection it was discovered that ring #19 on spine e is squashed with a rough edge.Upon request additional information was received on the returned catheter condition.There was no difficulty withdrawing the catheter through the sl0 8.5 f sheath that may have caused this damage.The returned catheter condition was not noticed prior to use of the catheter, upon withdrawal or prior to sending the catheter back for analysis.This finding is indicative of a reportable event because the rough edge could potentially harm the patient.The awareness date for this record is september 4, 2015 because that is when the product was received.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a pentaray nav eco catheter and a mapping issue occurred as it was not possible to rebuild the fast anatomical map volume.The returned device was visually inspected upon receipt and spine e was found with ring #19 squashed and the edge was rough which is why this complaint was reported to the fda.Per this condition the catheter outer diameters were measured and it was found within specifications.Further information received indicates that this condition was not noticed prior to sending the catheter back and that no resistance was noticed while withdrawing the catheter.During manufacturing all the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage from leaving the facility.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.The catheter was evaluated for eeprom, carto 3 and sensor functionality.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The customer complaint cannot be 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 ; 9497893837
• MDR Report Key: 5108216
• MDR Text Key: 27147000
• Report Number: 9673241-2015-00684
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• 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: Followup
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: D-1282-07-S
• Device Catalogue Number: D128207
• Device Lot Number: 17180288L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1