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

Model Number R7D282CT

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

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

Event Date 05/15/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a premature ventricular contraction (pvc) procedure with a decanav 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.Provided a video.A second device was used to complete the procedure.There was no adverse event reported on the patient.Device was not used in patient.The event was assessed as mdr reportable for an open pouch seal issue.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 07-jun-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.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 premature ventricular contraction (pvc) procedure with a decanav electrophysiology catheter and an open pouch seal issue occurred.The investigation was completed on 26-jun-2023.A video was received for evaluation following biosense webster's procedures.According to the video provided by the customer, the pouch of the device was observed unsealed; however, the video 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 video 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 of the returned device was performed following bwi procedures.The device was inspected, and no physical damage was observed.According to the video provided by the customer, the sterilization package was open compromising the sterility 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 be confirmed.All units are inspected prior 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.The damage reported, could be related to the process of storing, packaging or shipping of the device; however, this cannot be conclusively determined.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, 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: video evaluation: -investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the customer¿s reported ¿open pouch seal issue¿ and the video 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 evaluation: -investigation findings: no findings available (c20) / investigation conclusions: appropriate term/code not available (d17) were selected as related to the customer¿s reported ¿open pouch seal¿ issue and biosense webster inc.Analysis finding of ¿unable to analyze due to product return 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).

• 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: 17091081
• MDR Text Key: 317695445
• Report Number: 2029046-2023-01259
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: 10846835008791
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080425
• 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
• Report Date: 07/20/2023

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: 08/15/2023
• Device Model Number: R7D282CT
• Device Catalogue Number: R7D282CT
• Device Lot Number: 30873635M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• 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