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

Model Number D134804

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

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

Event Date 04/05/2022

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation (stsf) catheter.The pouch was ripped compromising sterility.It was reported that the stsf catheter was not sterile as the package was broken.The surgery was delayed 5 minutes due to the reported event.The procedure was successfully completed.No fragments were generated.There were no patient consequences.The device was not used on the patient.The open pouch seal issue was assessed as a mdr reportable product malfunction.

Manufacturer Narrative

The biosense webster, inc.Product 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 22-jul-2022.It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation (stsf) catheter.The pouch was ripped compromising sterility.It was reported that the stsf catheter was not sterile as the package was broken.The surgery was delayed 5 minutes due to the reported event.The procedure was successfully completed.No fragments were generated.There were no patient consequences.The device was not used on the patient.The open pouch seal issue was assessed as a mdr reportable product malfunction.Device evaluation details: according to the pictures provided by the customer, the package was sheared.The customer complaint was confirmed based on the picture received.The device was returned to biosense webster inc.(bwi) for evaluation.A visual inspection of the returned device was performed in accordance with bwi procedures.Visual analysis of the returned sample revealed a damaged package and a hole on the pouch.Manufacturing investigation was performed and concluded that the customer complaint is not related to manufacturing.Based on the condition that the sales unit box was received in, it is probable that the damage on the pouch was caused after the packaging process.Per internal procedures, a unit sale box with that type of damage is not allowed to be processed.An external cause could create the damage in the unit sale box and this could create the perforation on the pouch.A manufacturing record evaluation was performed for lot 30663380l and no internal actions related to the reported complaint condition were identified.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: investigation findings: packaging compromised (c160501) / investigation conclusions: cause not established (d15) / component code: packaging (g04094) were selected as related to the customer¿s reported pouch damage.H6.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.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: 14557048
• MDR Text Key: 294535786
• Report Number: 2029046-2022-01164
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2022

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: 11/01/2022
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30663380L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 06/23/2022; 07/22/2022
• Supplement Dates FDA Received: 07/20/2022; 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2021
• 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