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

Model Number D134805

Device Problems Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

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

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received a photograph of the complaint device.The bwi product analysis lab also received the physical 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.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 reference number: (b)(4).

Event Description

It was reported that a thermocool® smart touch® sf bi-directional navigation catheter package was received damaged.The pouch appears to be open.The shipment arriving today from distribution has a catheter, that the box is crushed and that the integrity of the device has been compromised.No patient involvement was reported.There was damage to the plastic tray inside of the packaging.This product was not used in a patient.Damaged packaging is not mdr-reportable.Open pouch seal is mdr-reportable.

Manufacturer Narrative

On 15-sep-2022, the product investigation was completed (both the photo analysis and the physical device evaluation).It was reported that a thermocool® smart touch® sf bi-directional navigation catheter package was received damaged.The pouch appears to be open.Device evaluation details: according to pictures provided by the customer, the outer box and the pouch were observed damaged.The pouch was not observed ripped.Also, the plastic tray was observed damaged and broken.The customer complaint was confirmed based on the picture received.Visual analysis of the returned device revealed that no damage or anomalies were observed on the smart touch bidirectional sf.No packaging was returned; therefore, we are unable to analyze the packaging condition.A manufacturing record evaluation was performed for the finished device number 30837532l, and no internal actions related to the reported complaint were identified.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 BI-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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15397835
• MDR Text Key: 306002651
• Report Number: 2029046-2022-02187
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30837532L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• 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