MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134701

Device Problems Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unspecified ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and post-procedure, the bwi product analysis lab identified a hole on the pebax.During ablation, physician tried to pull back ablation catheter for changing sheath.He realized that blood trapped in ablation catheter's tip.He swapped and irrigate but the blood was not out.Finally, he decided to change catheter.There were no issues when removal or withdrawing the catheter.The physician confirmed that they did not identify any catheter or pebax damage.No patient consequences were reported.The blood trapped on the catheter tip is not mdr-reportable.The hole in the pebax is mdr-reportable.

Manufacturer Narrative

The photo analysis and product investigation were completed.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, reddish material (presumably blood) was observed inside the pebax; however, no external damages were observed on the device.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and functional test of the returned device.Visual inspection was performed, and a hole was observed on the pebax surface with reddish material inside.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures.However, it could be related to the handling of the device during the procedure, but this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device batch number 30850656l, and no internal actions were identified.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17496242
• MDR Text Key: 320783070
• Report Number: 2029046-2023-01748
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2023

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: 07/18/2023
• Device Catalogue Number: D134701
• Device Lot Number: 30850656L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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
• Treatment: SL1 8.5FR SHEATH