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

Model Number 1085122RT

Device Problems Entrapment of Device (1212); Material Twisted/Bent (2981)

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

Event Date 03/15/2022

Event Type  malfunction  

Event Description

It was that an unknown patient underwent an atrial flutter right (r-afl) ablation procedure with a webster¿ electrophysiology catheter.During insertion of the catheter the catheter was twisted and damaged.The catheter was difficult to remove and the doctor had to do several maneuvers to remove it.The doctor was raising the catheter into the patient, and suddenly the catheter was twisted and damaged and the doctor had to do several maneuvers to remove it.He was finally been able to remove it from the patient without consequences.The procedure was successfully completed.The damage did not result in wires/internal components being exposed or lifted or sharp rings.It was difficult to advance during the insertion of the catheter to the coronary sinus, so physician decide to remove the catheter and it was difficult as well because he noticed under x-ray catheter shaped was bent.Finally he was able to remove the catheter out the patient.The doctor always pre-shapes the catheter before insertion.The sheath used was a abbott short sheath 5fr.Shaft bent is not mdr-reportable.Medical device entrapment with excessive manipulation required is mdr-reportable.

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).

Manufacturer Narrative

On 1-jun-2022, the product investigation was completed.It was that an unknown patient underwent an atrial flutter right (r-afl) ablation procedure with a webster¿ electrophysiology catheter.During insertion of the catheter the catheter was twisted and damaged.The catheter was difficult to remove and the doctor had to do several maneuvers to remove it.Device evaluation details: visual inspection testing was performed, in accordance with bwi procedures and the catheter failed due to the shaft being found bent.A dimensional test was performed, and the outer diameters of the device were found within specifications.There is no condition on the catheter that could be related to the entrapment of the catheter during the procedure.It should be noted that product failure is multifactorial.A manufacturing record evaluation was performed for the finished device 30658055l number, and no internal actions related to the reported complaint condition were identified.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 (b)(6) 2022, 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).

• Brand Name: WEBSTER¿ 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14059556
• MDR Text Key: 289193833
• Report Number: 2029046-2022-00764
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835000177
• UDI-Public: 10846835000177
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K892265
• 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: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1085122RT
• Device Catalogue Number: 1085122RT
• Device Lot Number: 30658055L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• 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
• Treatment: ABBOTT SHORT SHEATH 5FR.