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

Catalog Number	F5QA005CT
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.  a manufacturing record evaluation was performed for the finished device 30221068m number, and no internal actions related to the complaint was found during the review.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that during an ablation procedure before the transseptal was performed the webster catheter formed a knot.The customer provided images confirming the report.Once the knot formed it was very hard to maneuver the device.The knotted catheter was removed by using a larger sheath (st.Jude slo 10f).The procedure was cancelled.The physician did not consider procedure cancellation may have caused or contributed to a serious injury to the patient.The patient remained in observation for 1 additional day.No patient consequence was reported.The knotted catheter was assessed as a reportable malfunction.The procedure cancellation cancelation was assessed as not reportable as there was no risk to the patient as a result of the cancellation.
Additional Manufacturer Narrative
It was reported that during an ablation procedure before the transseptal was performed the webster catheter formed a knot.Once the knot formed it was very hard to maneuver the device.The knotted catheter was removed by using a larger sheath (st.Jude slo 10f).The procedure was cancelled.The patient remained in observation for 1 additional day.No patient consequence was reported.The biosense webster inc.(bwi) product analysis lab (pal) received pictures for analysis.The photograph investigation was completed on (b)(6)2019.According to the pictures provided by the customer, it was observed that the catheter formed a knot.The customer complaint is confirmed.However, the device has not been returned for analysis.If the device is received in the future, the product analysis will be perform as appropriate in order to find the potential root cause of complaint.A manufacturing record evaluation was performed for the finished device 30221068m number, and no internal actions related to the complaint were found during the review.Information was received on 9/18/2019 that the patient was under local anesthesia.Then on (b)(6)2019 additional information was provided that the patient was treated the next day.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
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8932791
• Report Number: 2029046-2019-03577
• Device Sequence Number: 18895572
• Product Code: DRF
• UDI-Device Identifier: 10846835007183
• UDI-Public: 10846835007183
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K892265
• 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): 08/06/2019

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: 04/23/2022
• Device Catalogue Number: F5QA005CT
• Device Lot Number: 30221068M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 10/04/2019
• 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: ST. JUDE SLO 10F SHEATH