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

Model Number D134805

Device Problems Material Puncture/Hole (1504); Insufficient Information (3190)

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

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 1/28/2021.The device evaluation was completed on 4/7/2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and force reading evaluation of the returned device.Visual analysis of the returned sample revealed reddish material in the pebax was observed on the smart touch bidirectional sf catheter.Magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor feature was tested and it was working properly, the force values were observed within specifications.Sem analysis show evidence of mechanical damage and a hole on the pebax surface.Object that cause the damage is unknown.No other anomalies were observed.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use contain the following warning stated in the carto 3 system manual: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.Regarding the additional finding observed, the instruction for use contains the following information: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

On january 28, 2021, this thermocool® smart touch® sf bi-directional navigation catheter was received by the biosense webster product analysis lab as an extra product under manufacturer reference number (b)(4).Manufacturer reference number (b)(4) was assessed as not reportable for a force issue.The visual finding on (b)(6) 2021 from the biosense webster failure analysis lab for this extra product received was that there was reddish material found in the pebax.Therefore, additional analysis was performed.The scanning electron microscope (sem) analysis showed evidence of mechanical damage and a hole on the pebax surface.Object that caused the damage was unknown.No other anomalies were observed.This hole on the pebax was assessed as a reportable lab finding.An investigation was performed to determine if there was an existing manufacturer reference number for this extra product received.Additional information was received stating that this product did not belong to (b)(4) complaint.In addition, we were unable to determine if there was an existing manufacturer reference number for this device.Since the returned catheter condition has been assessed as a reportable malfunction, we have made the decision to create a related manufacturer reference number under (b)(4) to conservatively report this returned catheter condition.The awareness date for this reportable lab finding is march 26, 2021.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11711017
• MDR Text Key: 268152186
• Report Number: 2029046-2021-00646
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2021

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: 09/17/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30433408M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2020
• 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