MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number BNI35DFH

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® sf nav bi-directional catheter wherein product sterility was compromised.It was reported the packaging of the catheter was ripped, so the catheter wasn¿t sterile anymore.They had to open a new one.There were no patient consequences.Additional information received indicated the cardboard packaging was okay but the inner packaging (white back and clear front) was torn open.There was no damage to the pouch seal per se but it looked like someone opened it before.The catheter was not used on the patient because it wasn¿t sterile anymore.It looked fine though, so no obvious damage.

Manufacturer Narrative

It was reported that a patient underwent a procedure with a thermocool® sf nav bi-directional catheter wherein product sterility was compromised.It was reported the packaging of the catheter was ripped, so the catheter wasn¿t sterile anymore.They had to open a new one.There were no patient consequences.Additional information received indicated the cardboard packaging was okay but the inner packaging (white back and clear front) was torn open.There was no damage to the pouch seal per se but it looked like someone opened it before.The catheter was not used on the patient because it wasn¿t sterile anymore.It looked fine though, so no obvious damage.Device evaluation details: the thermocool® sf nav bi-directional catheter was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed no damages or anomalies on the device.Since the original package was not returned, no analysis could be performed.A manufacturing record evaluation was performed and no internal action was found during the review.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 ref.# pc-001199793.

Manufacturer Narrative

On 18-oct-2022, the contact information of the head of heart centre was provided and appropriate e1.Initial reporter fields have been populated.It was reported, the actual user is unknown.E1.Initial reporter phone: (b)(4) on 19-oct-2022, the bwi product analysis lab received the complaint device for evaluation.The product 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.# (b)(r4) on 13-nov-2022, it was determined the incorrect h6.Medical device problem codes of ¿packaging problem (a0205)¿ and ¿delivered as unsterile product (a020701)¿ were reported.The event is better represented with code ¿tear, rip or hole in device packaging (a020504)¿ as such has been updated to the appropriate field.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15592763
• MDR Text Key: 307070613
• Report Number: 2029046-2022-02505
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835003215
• UDI-Public: 10846835003215
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2022

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: 05/14/2024
• Device Model Number: BNI35DFH
• Device Catalogue Number: BNI35DFH
• Device Lot Number: 30563955L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 10/18/2022; 11/18/2022
• Supplement Dates FDA Received: 11/15/2022; 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2021
• 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: THERMOCOOL SF CARTOXP,D-F,TC.