MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D134701
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 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).
Event or Problem Description
It was reported there were three thermocool smarttouch sf catheters with perforated primary packaging as the product loses sterility.No patient consequence reported.Additional information was received which indicated that there was no detection made upon receipt of the product.The three thermocool smarttouch sf catheters were assessed as mdr reportable.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 02-sep-2025.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).
Additional Manufacturer Narrative
It was reported the thermocool smarttouch sf catheter with perforated primary packaging as the product loses sterility.No patient consequence reported.The investigation was completed on 21-oct-2025.A picture was received for evaluation following johnson & johnson medtech (j&j medtech) procedures.According to the pictures provided by the customer, the pouch of the catheter was observed damaged; however, based on the photo it is not possible to determine if the package was perforated.Since the pouch was observed damaged on the photo provided by the customer, the issue reported by the customer was confirmed.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.The product was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection was performed following j&j medtech procedures.Visual analysis revealed stress mark in the pouch in the handle area; and that the package was also ruptured in the handle area.Also, no packaging was returned for further investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The stress marks and rupture of the package could be related to the open pouch seal issue reported by the customer, the complaint was confirmed.A special manufacturing investigation was performed and it was concluded that the stress marks and rupture of the pouch observed did not occur during its manufacturing process.The potential cause of issues observed could be related to the manipulation of the device during the distribution of the device to the hospital; however, this could not be conclusively determined.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo 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 SMARTTOUCH SF
• Common Device Name: 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22840984
• Report Number: 2029046-2025-02749
• Device Sequence Number: 9580594
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: (01)10846835009774(17)280327(10)31587911L
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: D134701
• Device Lot Number: 31587911L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 10/21/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/24/2025; 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF UNID, TC, D; THMCL SMTCH SF UNID, TC, D; THMCL SMTCH SF UNID, TC, D
• Patient Sex: Unknown