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

Model Number R7F282CT

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 10/15/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a decanav electrophysiology catheter and a sterilization compromised issue occurred.The product was desterilized during opening.No patient consequences reported.No damage was observed on the pouch.The product was desterilized during the opening process by the nurse.The device was not used on the patient.When the nurse opened the pouch and hold it by its end, the cardboard folded and the product touched something non sterile.The product and the packaging was discarded.The customer complaint about the carboard rigidity.The event was assessed as a mdr reportable sterilization compromised issue.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30591666m number, and no internal action related to the complaint was found during the review.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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12776308
• MDR Text Key: 285192407
• Report Number: 2029046-2021-01911
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2021

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: 06/23/2022
• Device Model Number: R7F282CT
• Device Catalogue Number: R7F282CT
• Device Lot Number: 30591666M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• 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