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	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi product analysis lab (pal) received the device for evaluation.Upon initial inspection, no visual damage or anomalies were observed.The product investigational analysis completed 5/21/2020.The pouch was not returned for analysis.The manufacture process was reviewed and there are several inspection points to detect and segregate open pouch and other issues in order to prevent this type of damage from leaving the facility.Afterwards, the shipping history was reviewed, and no issues were observed.A total of eight devices were delivered to the account.In addition, a search of related complaints with the same lot number was performed without any results.A manufacturing record evaluation was performed, and no internal actions were identified.The experience reported by the customer was unable to confirmed since the pouch was not returned for analysis.In addition, the manufacture process was reviewed and there are several controls to avoid this kind of issue from leaving the facility and no other complaints were reported form the same lot number.In conclusion, the root cause of the reported issue 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 at the hospital.However, this cannot be conclusively determined.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a webster ® cs catheter with ez steer® technology and auto id, and an open pouch seal issue occurred.It was reported that the webster cs catheter with auto id technology was not completely sealed inside of the box.When the catheter was removed from the box to open the packaging is when it was noticed to be open.The catheter was not used on the patient.The catheter was replaced, and the issue resolved.No adverse patient consequences were reported multiple attempts via email were made to obtain clarification regarding the event with no response.The clinician the contacted the biosense webster inc.(bwi) representative via phone call on 04/23/2020, the bwi representative was the one who opened the catheter.The outer packaging was intact.The pouch seal was completely opened, and the catheter was obviously not sterile.No other abnormalities were observed.The observed open pouch seal issue has been assessed as an mdr reportable malfunction.Based on the additional information provided, the awareness date of this event is being changed to 04/23/2020.

• 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: 10081202
• Report Number: 2029046-2020-00617
• Device Sequence Number: 19542067
• Product Code: DRF
• UDI-Device Identifier: 10846835002409
• UDI-Public: 10846835002409
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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: 12/10/2022
• Device Model Number: BD710DF282CT
• Device Catalogue Number: BD710DF282CT
• Device Lot Number: 30330695M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1