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	BD710DF282CT
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.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).
Event or Problem Description
It was reported that a patient underwent a procedure with a webster ® cs catheter with ez steer® thechnology and auto id, and a sterilization compromised issue occurred.The webster ® cs catheter with ez steer® thechnology and auto was no longer sterile upon unpacking.The two plastic part used to package the catheter where not properly joined.Thus, as the nurse opened the package, the catheter head was no longer fixed, and touched a non-sterile surface.The product was not used on the patient.No consequences for the patient occurred.It was stated that the packaging was discarded and only the product was kept.The issue reported has been assessed as an mdr reportable sterilization compromised issue.
Additional Manufacturer Narrative
On(b)(6) 2020, the bwi product analysis lab received the device for evaluation.The product investigation has since been completed.It was reported that a patient underwent a procedure with a webster ® cs catheter with ez steer® thechnology and auto id and a sterilization compromised issue occurred.The webster ® cs catheter with ez steer® thechnology and auto was no longer sterile upon unpacking.The two plastic part used to package the catheter where not properly joined.Thus, as the nurse opened the package, the catheter head was no longer fixed and touched a non-sterile surface.The product was not used on the patient.No consequences for the patient occurred.It was stated that the packaging was discarded and only the product was kept.Device evaluation details: complaint catheter was inspected, and it was found in good normal condition.The issue reported by the customer was unable to analyze since the original packaging was not returned for analysis.However according to pictures provided by customer, the plastic tray of the catheter was observed separated and not fixed properly.A manufacturing record evaluation was performed for the finished device 30372010m number, and no internal action was found during the review.The customer complaint was confirmed.The root cause of plastic tray separated cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.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: 10519542
• Report Number: 2029046-2020-01223
• Device Sequence Number: 16824400
• Product Code: DRF
• UDI-Device Identifier: 10846835002409
• UDI-Public: 10846835002409
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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: 03/19/2023
• Device Model Number: BD710DF282CT
• Device Catalogue Number: BD710DF282CT
• Device Lot Number: 30372010M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1