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

Catalog Number	R7D282CT
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	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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 that a patient underwent an atrioventricular (av) node ablation procedure with a decanav electrophysiology catheter and when the device was first opened, it was noticed that there was hole in the product packaging, and the pouch seal was compromised.It appeared as though the decanav catheter "plunger" had "rubbed through the packaging," creating a hole.This device was never used on the patient.The decanav catheter was replaced and the procedure continued without any issues.No patient consequences were reported.
Additional Manufacturer Narrative
On 18-nov-2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.D4 primary udi number has been updated to (b)(4).It was reported that a patient underwent an atrioventricular (av) node ablation procedure with a decanav electrophysiology catheter and when the device was first opened, it was noticed that there was hole in the product packaging, and the pouch seal was compromised.It appeared as though the decanav catheter "plunger" had "rubbed through the packaging," creating a hole.This device was never used on the patient.The decanav catheter was replaced and the procedure continued without any issues.No patient consequences were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection of the returned device was performed following j&j procedures.Visual analysis revealed no damage or anomalies on the device.According to the provided pictures by the customer, it look like that the pouch appeared to have been smashed, crumpled, but the picture do not provide enough evidence to identify if there was hole in the pouch.The damage identified could be related to the reception, storage or shipping process, however, this cannot be conclusively determined.Finally, further investigation could not be performed as the pouch and packaging were not returned for analysis.A manufacturing record evaluation was performed for the finished device number lot 31418780m and no internal action related to the complaint was found during the review.The pouch issue reported by the customer was confirmed based on the picture provided by the customer.The potential cause of the damage cannot be established.The instructions for use (ifu) contain the following general instruction and information: verify product receipt and inspect package and product for signs of damage or sterility compromise.Do not use if the package is open or damaged.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through j&j's quality system.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
• Common Device Name: 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: 20616635
• Report Number: 2029046-2024-03566
• Device Sequence Number: 15316854
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: (01)10846835008791(17)250814(10)31418780M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: R7D282CT
• Device Lot Number: 31418780M
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: NGEN GENERATOR
• Patient Sex: Unknown