MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number R7F282CT

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

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

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

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 followup report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter and the sterile packaging was found opened.It was reported that when the catheter packaging was opened, they found the sterile packaging inside was already opened.The inside looked like it had been opened already.The packaging was not preserved after the procedure.No pictures were taken of the package.The device was not used for the procedure and was never placed into the sterile field.The catheter itself was set aside for return.No adverse patient consequence was reported.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter and the sterile packaging was found opened.It was reported that when the catheter packaging was opened, they found the sterile packaging inside was already opened.The inside looked like it had been opened already.The packaging was not preserved after the procedure.No pictures were taken of the package.The device was not used for the procedure and was never placed into the sterile field.The catheter itself was set aside for return.No adverse patient consequence was reported.Device evaluation details: 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 of the returned sample revealed no damage or anomalies on the device.Since no packaging was returned, further investigation could not be performed.A manufacturing record evaluation was performed for the finished device number lot 30981691m and no internal action related to the complaint was found during the review.The issue reported by the customer could not be confirmed during the product investigation since no packaging was returned.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.H 6.Investigation conclusions code of ¿appropriate term/code not available (d17)¿ refers to unable to analyze due to the packaging not being returned.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: DECANAV ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 18602484
• MDR Text Key: 335077412
• Report Number: 2029046-2024-00326
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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: 01/16/2024
• Device Catalogue Number: R7F282CT
• Device Lot Number: 30981691M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2023
• 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