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

Model Number D-1348-01-S

Device Problems Hole In Material (1293); Unable to Obtain Readings (1516); Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)

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

Event Date 06/22/2017

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.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart touch bidirectional sf catheter.During the procedure, the temperature suddenly did not display.The catheter was exchanged.The procedure was completed without patient consequence.This temperature issue was assessed as not reportable as the ablation cannot be performed since there was no radiofrequency energy applied.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster failure analysis lab received the product for analysis on (b)(6) 2017 and discovered that it had clear material stuck to the tip of catheter.This foreign material was assessed as a reportable malfunction.If foreign material is found adhered to the catheter within the usable length, it can cause embolism or stroke.Therefore, the awareness date for this finding was (b)(6) 2017.During additional analysis on (b)(6) 2017 by the biosense webster failure analysis lab, the pebax was found damaged with a hole and scratches.The hole in the pebax was assessed as a reportable malfunction since the pebax integrity had been compromised.Therefore, the awareness date for this finding was (b)(6) 2017.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart touch bidirectional sf catheter.During the procedure, the temperature suddenly did not display.The catheter was exchanged.The procedure was completed without patient consequence.The returned device was visually inspected and it was observed clear material stuck on the tip of the catheter.Then, during the second visual inspection it was found that there was pebax damage with a hole and scratches without foreign material on the tip, this could be related to the decontamination process during the first inspection.Per the event, the catheter was tested for electrical performance and stockert compatibility and it was found within specifications.For the condition observed a scanning electron microscope (sem) testing was performed and the results showed evidence of a hole, stress marks and mechanical damage on the surface of the pebax.There were also ductile dimples that are characteristic of an elongation.It is possible that damage was generated with an unknown object and pebax was stretched and/or pulled with excessive force.No other anomalies were observed and no foreign material was found on pebax.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.During the manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint cannot be confirmed.The root cause of the damage remains unknown.It could be related to the handling of the product.However, this cannot be conclusively determined.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6829438
• MDR Text Key: 86280578
• Report Number: 9673241-2017-00674
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: (01)10846835010145(11)170315(17)180227(10)17651667L
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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: 07/05/2017

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: 02/27/2018
• Device Model Number: D-1348-01-S
• Device Catalogue Number: D134801
• Device Lot Number: 17651667L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 07/05/2017
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• 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