MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER; CATHETER, ELECTRODE RECORDING

Model Number	F5QF005CT
Medical Device Problem Codes	Material Twisted/Bent (2981); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a webster catheter and a knotted catheter issue occurred.Right ventricle catheter was knotted in the vessel.It was too soft although it was a new catheter.Physician changed the catheter.The new one was better.No patient consequence was reported.There was difficulty experienced while maneuvering the catheter.There was no detachment of any component.The loop/tip became unknotted.The issue did not result in exposure of any internal catheter components or sharp edges.The knotted catheter issue was assessed as a mdr reportable malfunction.
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).During an internal review on 26-aug-2021, noted a correction to the initial as the physician information was not included.Therefore, added this information to e.Initial reporter.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 29-aug-2021.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).
Additional Manufacturer Narrative
It was reported that a patient underwent an ablation procedure with a webster catheter.Right ventricle catheter was knotted in the vessel.It was too soft although it was a new catheter.Physician changed the catheter.The new one was better.No patient consequence was reported.There was difficulty experienced while maneuvering the catheter.There was no detachment of any component.The loop/tip became unknotted.The issue did not result in exposure of any internal catheter components or sharp edges.Device evaluation was completed on 01-oct-2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that a bent in the shaft was observed on the webster catheter.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device 30589790m number, and no internal action related to the complaint was found during the review.It should be noted that product failure is multifactorial.The instructions for use contain the following the sterile packaging and catheter should be inspected prior to use.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 30-sep-2021, added the ¿h6.Medical device problem code" of ¿appropriate term/code not available (a27)¿ to represent that it was customer preference related for the issue that it was reported that it was too soft.
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) initially the device evaluation was completed on (b)(6)-2021 and was submitted under 3500a follow-up #3.During an internal review on (b)(6)-2021, a correction to the device evaluation was noted.Below is the correction device evaluation: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that a bent in the shaft was observed on the webster catheter.A manufacturing record evaluation was performed for the finished device 30589790m number, and no internal action related to the complaint was found during the review.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The issue is not related to the manufacturing process, as all devices are manufactured, inspected, and released to approved specifications.The instructions for use contain the following: ¿the sterile packaging and catheter should be inspected prior to use¿.The root cause of the product failure can be multifactorial.Based upon the event description, the device got knotted in the vessel.It is likely that the bent occurred during the manipulation to unknot the catheter and to remove it from the vessel.

• Brand Name: WEBSTER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12375986
• Report Number: 2029046-2021-01412
• Device Sequence Number: 11064477
• Product Code: DRF
• UDI-Device Identifier: 10846835007305
• UDI-Public: 10846835007305
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K892265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/31/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2024
• Device Model Number: F5QF005CT
• Device Catalogue Number: F5QF005CT
• Device Lot Number: 30589790M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 08/26/2021; 08/29/2021; 09/30/2021; 10/28/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 08/27/2021; 08/31/2021; 10/26/2021; 10/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BRAND CATHETER.; UNKNOWN BRAND CATHETER