MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS CATHETER WITH EZ STEER THECHNOLOGY AND AUTO ID; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number	BD710FJ282CT
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
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.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that during a cardiac ablation procedure, right after the webster ® cs catheter with ez steer® thechnology and auto id was removed from the box, it was noticed it had a bent of almost 50-degree angle.The catheter appears to be scraped through the body of the catheter.It was also reported there was a small film looking like material on one side of the shaft.The catheter was replaced, and the issue was resolved.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.There¿s no indication that internal components were exposed.There are no details on how far from the distal tip was the foreign material found.With the information available, this is being conservatively coded and reported as ¿foreign material on usable length of catheter¿.Bent shaft is not mdr-reportable.Foreign material is mdr-reportable.
Additional Manufacturer Narrative
On (b)(6) 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).
Additional Manufacturer Narrative
On (b)(6) 2021, the product investigation was completed.It was reported that during a cardiac ablation procedure, right after the webster ® cs catheter with ez steer® thechnology and auto id was removed from the box, it was noticed it had a bent of almost 50-degree angle.The catheter appears to be scraped through the body of the catheter.It was also reported there was a small film looking like material on one side of the shaft.The catheter was replaced, and the issue was resolved.Device evaluation details: visual analysis of the returned sample revealed a white foreign material along the webster cs catheter, no bents or damage were observed on the catheter shaft.A fourier transform infrared spectroscopy test (ftir) was performed to the material, and the infrared pattern obtained suggest the presence of a vinyl-acetate base material, these type materials are commonly used in polymeric, paint, and coating industries.The source of origin remains unknown.In addition, a manufacturing investigation was performed, and it was concluded that this issue is not related to the process since this material is not used on the manufacturing floor.A manufacturing record evaluation was performed for the finished device [30377254m] number, and no internal actions related to the reported complaint condition were identified.The root cause of the foreign material found on the device cannot be related to the manufacturing process.It should be noted that the issue found is multifactorial.The instructions for use contain the following recommendations: before use, inspect the packaging.Do not use if open or 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: WEBSTER CS CATHETER WITH EZ STEER THECHNOLOGY AND AUTO ID
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11476349
• Report Number: 2029046-2021-00364
• Device Sequence Number: 19960967
• Product Code: DRF
• UDI-Device Identifier: 10846835002423
• UDI-Public: 10846835002423
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2021

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: 03/26/2023
• Device Model Number: BD710FJ282CT
• Device Catalogue Number: BD710FJ282CT
• Device Lot Number: 30377254M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/22/2021; 04/16/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/07/2021; 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1