MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Model Number D-1347-02-S

Device Problems Hole In Material (1293); Device Displays Incorrect Message (2591); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2015

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.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool smart touch uni-directional navigation catheter approved under pma # p030031/s053.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool smarttouch sf uni-directional nav catheter and a catheter recognition issue occurred as the system did not recognize the mapping catheter when it was connected.Error indicated ¿no catheter id.¿ the system knew there was a connection as the catheter progress bar worked each time the catheter was disconnected and reconnected.The cable was changed with no resolution.The catheter was changed and the problem resolved.There was no consequence to the patient and the procedure was completed successfully.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 and during visual inspection it was discovered that there was a hole was in the pebax.Upon request additional information was received on the finding.There was no difficulty in removing the catheter from the patient.This condition was not noticed prior to use, upon withdrawal or before sending the catheter back for analysis.This finding is indicative of a reportable event due to the break in the integrity of the catheter which could pose a risk to patient.The awareness date for this record is october 15, 2015 because that is when the damage was discovered.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a thermocool® smarttouch® sf uni-directional nav catheter and a catheter recognition issue occurred as the system did not recognize the mapping catheter when it was connected.Error indicated ¿no catheter id.¿ biosense webster failure analysis lab received the device for evaluation and during visual inspection it was discovered that there was a hole was in the pebax which is why this complaint was reported to the fda.The product was received for this pi; however during the product analysis, after the initial 3500a was submitted to the fda, it was found that the returned catheter does not belong to the reported complaint.Multiple attempts were performed to clarify the discrepancy but we were unable to clarify.Since the returned catheter did not match the reported catheter, a new complaint was created to address the reportable analysis finding.A new 3500a report will be submitted separately to further address the reportable finding (manufacturer's ref.No: (b)(4)).A device history record (dhr) was performed based on the lot number provided by the customer 17145445l, not on the product that was received.During this review it was noticed that catheter was calibrated with lower cases as d-1347-02-s instead of d-1347-02-s.This condition caused the carto® 3 mapping system to not be able to recognize the catheter.The customer complaint has been verified.It was found that the root cause of the issue was a manufacturing failure while using the calibration system.An internal corrective action was created to address this issue.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 5212378
• MDR Text Key: 31096224
• Report Number: 9673241-2015-00806
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/25/2015

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: 11/30/2015
• Device Model Number: D-1347-02-S
• Device Catalogue Number: D134702
• Device Lot Number: 17145445L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2015
• Initial Date FDA Received: 11/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2014
• 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