MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER COMPLI; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	F5ADP282RT
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that an unknown patient underwent an unknown ablation procedure with a webster compli.The sterile package was not intact.Interior package damaged.It was reported by physician that the sterilization package was broken and product was dirty.So they didn¿t use the catheter in/on patient, replaced with other new one.No patient was reported injured.Open pouch seal is mdr-reportable.
Additional Manufacturer Narrative
On 9-dec-2021, the bwi 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).
Additional Manufacturer Narrative
On (b)(6)2021, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a webster compli.The sterile package was not intact.Interior package damaged.It was reported by physician that the sterilization package was broken and product was dirty.So they didn¿t use the catheter in/on patient, replaced with other new one.No patient was reported injured.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the webster catheter.The device was returned without its original package; the test cannot be performed due to the returned catheter.A manufacturing record evaluation was performed for the finished device [30581256m] number, and no internal actions related to the reported complaint condition were identified.The instructions for use contain the following warning: inspect the catheter packaging before use.If the package is open or damaged, return the catheter to biosense webster.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: WEBSTER COMPLI
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12750207
• Report Number: 2029046-2021-01882
• Device Sequence Number: 4557945
• Product Code: LDF
• UDI-Device Identifier: 10846835000467
• UDI-Public: 10846835000467
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K892265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2022
• Device Model Number: F5ADP282RT
• Device Catalogue Number: F5ADP282RT
• Device Lot Number: 30581256M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 12/09/2021; 12/16/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 12/14/2021; 01/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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
• Patient Sex: Unknown