MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133605IL

Device Problems Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)

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 a procedure with a thermocool® smart touch¿ electrophysiology catheter and an open pouch seal issue occurred.Primary package unsealed.Before the procedure, the sterilization package was found unsealed after the carton was opened.A second device was used to complete the procedure.There was no adverse event reported on the patient.Device was not used in the patient.Additional information was received.The event description was updated to state, ¿the sterilization package was found unsealed after the carton was opened.¿ the device was not used on the patient.The event was assessed as non mdr reportable for an open pouch seal issue.

Manufacturer Narrative

The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ electrophysiology catheter approved under p030031/s053.The product has not returned for analysis, however, a pictures were 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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).

Manufacturer Narrative

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter and an open pouch seal issue occurred.The investigation was completed on 04-jul-2023.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the pouch of the device was observed unsealed; however, the photo does not provide sufficient information to determine if the device left the johnson and johnson facilities in this condition.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.According to the photo provided by the customer, the sterilization package seal was opened, compromising the sterilization of the catheter.However, the package was not returned for analysis.Due to this condition, the issue reported by the customer was not possible to confirm.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was not confirmed for the device evaluation, due to the package was not returned for analysis.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: picture investigation: investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the picture provided.Investigation findings: packaging compromised (c160501) / investigation conclusions: cause not established (d15) / component code: packaging (g04094) were selected as related to the customer¿s reported ¿open pouch seal¿ issue.Device investigation: investigation findings: no findings available (c20) / investigation conclusions: appropriate term/code not available (d17) were selected as related to the biosense webster¿s inc.Product analysis lab unable to analyze due to the product returned condition.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 27-jul-2023, noted a correction to 3500a follow-up #1.In h10.Additional manufacturer narrative it was reported, ¿the bwi product analysis lab received the device for evaluation on 31-may-2023.¿ however, fields d 9.Device available for evaluation?, date device returned to manufacturer and d 9.Is device returned to manufacturer? were not processed in error.Therefore, processed.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 31-may-2023.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).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 16970011
• MDR Text Key: 315683181
• Report Number: 2029046-2023-01115
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2023
• Device Catalogue Number: D133605IL
• Device Lot Number: 30821721M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• 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: UNKNOWN BRAND CATHETER.