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

Model Number D-1282-11-S

Device Problems Bent (1059); Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2015

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

The 3500a report #9673241-2016-00068 (b)(4) was submitted as reportable per the returned catheter condition.However, after further analysis and investigation, it was found that this product did not belong to (b)(4) and we were unable to match this product with any other complaint from this account.Therefore, since this is a reportable returned catheter condition, we are taking the conservative approach and have created another complaint under (b)(4) to document and report this reportable malfunction.The biosense webster failure analysis lab discovered while assessing the returned catheter condition, that when the insertion tool (protective tubing) pushed down on the spines, spine a was bent down causing white stress and it was damaged at the nitinol stem transition area.Also spine a was wrinkled and bent between the marker ring and ring #2 causing the proximal to be lifted up and sharp.Rings #3 and #4 were squashed leaving the edges rough.Additional clarification was received on the returned catheter condition.This returned catheter condition was not noticed.There was no resistance or difficulty during insertion or removal of the catheter.The sl1 8.5 fr sheath was used.Therefore, since it is not known when these issues occurred (before, during or after the procedure), we are taking the conservative approach and reporting this returned catheter condition.The electrode damages described as sharp and rough have been assessed as reportable as they may cause damage to vascular endothelial linings during the withdrawal of the catheter and sheath.

Manufacturer Narrative

The 3500a report #9673241-2016-00068 manufacturer reference number (b)(4) was submitted as reportable per the returned catheter condition.However, after further analysis and investigation with the customer, it was found that this product did not belong to manufacturer reference number (b)(4).We were also unable to match this returned product with any other complaint for this account in the biosense webster inc.Complaint system.Therefore, since the returned catheter condition was assessed as a reportable malfunction, a separate complaint was created under manufacturer reference number (b)(4) to document and report this reportable malfunction.(b)(4).This product was received as a wrong product for 3500a report #9673241-2016-00068 manufacturer reference number (b)(4); there is no malfunction reported for it.A search was performed in the complaint system and no complaint was found with a missing device for this catheter lot number.The returned device was visually inspected and the insertion tool was found pushed down on the spines.Due to this action, spine a was found bent down, wrinkled and with damaged electrodes.Per these conditions, the catheter outer diameters were measured and they were found within specifications.The catheter was introduced in an instructions for use (ifu) recommended sheath and no resistance was noticed during this procedure.The catheter was evaluated for eeprom, and the functionality of the sensor catheter was tested on carto system.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was recognized by carto 3 system, however error 116 was displayed.The catheter was then dissected and it was determined that the root cause was an internal wire broken of the sensor at the connector area.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 root cause of the sensor wire breakage cannot be determined.Regarding the catheter condition; based on the available analysis finding results, the failure mode does not appear to be caused by any internal biosense webster inc.Processes since all units are inspected prior leaving the facility.

• 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: 5533640
• MDR Text Key: 41678581
• Report Number: 9673241-2016-00209
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: D-1282-11-S
• Device Catalogue Number: D128211
• Device Lot Number: 17265337L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2015
• 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