MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1327-01-S

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2015

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 smart touch bidirectional catheter.The product was returned to the biosense webster failure analysis for analysis and it was discovered that the integrity of the pebax had been compromised.The initial reported force issue was assessed as not reportable as 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.The procedure was completed with no patient consequence.The biosense webster failure analysis lab received the product for evaluation.On (b)(6) 2015, it was discovered that the that the sensor sleeve (pebax) had one cut on the surface and two cuts that were deep which let reddish brown material inside the pebax.Additional clarification was received on this condition.There was no difficulty experienced while maneuvering the catheter or during the withdrawal of the catheter.This condition was not noted prior to returning the catheter to biosense webster.It was confirmed that there was no patient consequence.Since the pebax integrity has been compromised, this issue has been assessed as a reportable malfunction.The awareness date was reset to (b)(6) 2015.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart touch bidirectional catheter.When the catheter was inserted for ablation, zeroing was re-conducted and the ablation was started.The contact force value was displayed 40g-hi at the same time of ablation was started.When the ablation was stopped, the contact force value was displayed 5g-10g as normally.Zeroing and the ablation were re-conducted but the issue continued.This catheter was used to complete the procedure.The returned device was visually inspected upon receipt and a cut on the surface of pebax was observed allowing reddish material enter inside the area.Per this condition, a scanning electron microscope (sem) testing was performed over the damaged area of catheter and it was found that the pebax external surface presented evidence of scratches and displacement material caused by an unknown object.An internal corrective action has been opened to investigate this type of pebax damage.The catheter was evaluated for screening test and force calibration check and catheter passed both tests.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.The force feature was working properly.Finally, the force sensor values were 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.The customer complaint cannot be confirmed.An internal corrective action has been opened to investigate this type of pebax damage.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 5288219
• MDR Text Key: 33940176
• Report Number: 9673241-2015-00911
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031/S053
• 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: 10/21/2015

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: 05/31/2016
• Device Model Number: D-1327-01-S
• Device Catalogue Number: D132701
• Device Lot Number: 17259183M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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