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 Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

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

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray navigational eco catheter.There was a 105 sensor error with the pentaray navigational eco catheter.They changed out the catheter cable.However, this did not resolve the issue.Therefore, they changed out the pentaray navigational eco catheter and this did resolve the issue.The procedure was continued with no patient consequence.This issue was easily detectable by the user.The catheter was inoperable , since it cannot be visualized on the carto 3 system.The user will have to replace the catheter.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.Therefore, this issue was assessed as not reportable.The biosense webster failure analysis lab discovered on january 11, 2016 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.The awareness date was reset to january 11, 2016.

Manufacturer Narrative

Originally this complaint was assessed as not reportable for the 105 sensor error.The product was received for analysis and the returned catheter condition was assessed as a reportable malfunction.However, after further analysis and investigation, it was found that this product did not belong to this complaint 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 manufacturer reference number (b)(4) to document and report this reportable malfunction.For manufacturer reference number (b)(4) (9673241-2016-00068), 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.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) for the lot number 17258538l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.Methods: no testing methods performed.(b)(4).Results: no results available since no evaluation performed.(b)(4).Conclusion codes: device not returned.(b)(4).(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 ; 9497893837
• MDR Report Key: 5429383
• MDR Text Key: 38768861
• Report Number: 9673241-2016-00068
• 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: 02/10/2016
• 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-1282-08-S
• Device Catalogue Number: D128208
• Device Lot Number: 17258538L
• 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?: No
• Date Device Manufactured: 06/05/2015
• 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