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

Catalog Number R7F282CT

Device Problems Break (1069); Device-Device Incompatibility (2919); Positioning Problem (3009)

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

Event Type  malfunction  

Manufacturer Narrative

Device investigation details: available information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31182842m and no internal action related to the complaint was found during the review.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a decanav electrophysiology catheter and the tip was broken.It was reported the tip of the catheter looks broken and it was also difficult to bend the catheter.The physician felt uncomfortable to manipulate.There was resistance during insertion of the catheter.There was no wires being exposed and no sharp or lifted rings.The catheter was not pre-shaped and and 8.5 french short sheath was used.There was no patient consequence.

Manufacturer Narrative

On 14-mar-2024, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a decanav electrophysiology catheter and the tip was broken.It was reported the tip of the catheter looks broken and it was also difficult to bend the catheter.The physician felt uncomfortable to manipulate.There was resistance during insertion of the catheter.There was no wires being exposed and no sharp or lifted rings.The catheter was not pre-shaped and and 8.5 french short sheath was used.There was no patient consequence.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed marks of stress next to the dome area.Additionally, the tip was broken close to the transition area with the shaft, and a braid wire was observed exposed in this area where ¿a hole¿ was noticed.A dimensional inspection was performed, and the device passed within specification.A deflection test was performed, and the curve was deflecting within specifications.Based on the records of the device there were no deviations from the process flow and the device was manufactured by the specifications, it is unclear how this damage occurred as the reported event was noticed mid-procedure, and resistance was experienced during the usage of the device.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The broken tip and resistance with sheath issues reported by the customer were confirmed; however, the deflection issue could not be confirmed.The potential cause of the broken condition cannot be determined, it could be related to the manipulation of the device during the procedure, however, this cannot be conclusively determined.The broken tip may be related to the resistance with sheath issue, however, this could not be conclusively determined.The instructions for use (ifu) advise to: do not use excessive force to advance or withdraw the catheter when resistance is encountered.Excessive force may cause dissection and/or perforation of coronary sinus or other cardiac structures.Prior to removal of the catheter, confirm that the thumb knob has been pulled back completely (straightened).Remove the catheter and dispose of it in an appropriate manner.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the customer¿s reported resistance and broken tip.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer's reported deflection (difficult to bend) issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: it was noticed the h6.Medical device problem code of ¿device-device incompatibility (a1702)¿ to account for the customer¿s reported ¿resistance issue¿ was inadvertently omitted from the 3500a initial medwatch.Code has now been added.

• 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: 18823150
• MDR Text Key: 337634574
• Report Number: 2029046-2024-00702
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Followup
• Report Date: 03/01/2024

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 Catalogue Number: R7F282CT
• Device Lot Number: 31182842M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 03/14/2024; 04/05/2024
• Supplement Dates FDA Received: 03/15/2024; 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2023
• 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
• Treatment: UNKNOWN 8.5 FRENCH SHORT SHEATH.