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

Model Number R7D282CT

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 Description

It was reported that an unknown patient underwent a premature ventricular contraction (pvc) ablation procedure with a decanav electrophysiology catheter.The tip was soiled causing sterilization to be compromised.Catheter tip soiling was noted after opening the package.The issue was resolved by changing the decanav catheter to another one.The procedure was completed without patient's consequence.Compromised sterilization is mdr-reportable.

Manufacturer Narrative

On 9-oct-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).

Manufacturer Narrative

On 15-oct-2021, the product investigation was completed.It was reported that an unknown patient underwent a premature ventricular contraction (pvc) ablation procedure with a decanav electrophysiology catheter.The tip was soiled causing sterilization to be compromised.Catheter tip soiling was noted after opening the package.The issue was resolved by changing the decanav catheter to another one.The procedure was completed without patient's consequence.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection test of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the decanav catheter.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 8-feb-2022, bwi received additional information regarding the event.There was no physical damage to the outer box or packaging.The device was secured properly in the tray and there was no damage to the device due to any part of the packaging being damaged.The customer did not provide detailed information/description of the tip of the device.The pouch was not damaged.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12531323
• MDR Text Key: 273299573
• Report Number: 2029046-2021-01629
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: 10846835008791
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup,Followup
• Report Date: 02/28/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2022
• Device Model Number: R7D282CT
• Device Catalogue Number: R7D282CT
• Device Lot Number: 30549274M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 10/09/2021; 10/15/2021; 02/08/2022
• Supplement Dates FDA Received: 10/13/2021; 10/25/2021; 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2021
• 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