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

Catalog Number	D728260RT
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation with a webster 20 pole catheter where the catheter became stuck in the fully deflected state.During the procedure, the catheter became stuck while fully deflected.The knob could be moved by the physician, but the catheter did not move with it.There was difficulty removing the catheter, but it was able to be removed safely from the patient¿s body, and no physical damage was noted on the catheter after removal.The catheter was replaced with a new one, and the case continued without patient consequence.It was noted that an unspecified diagnostic 8.5 french sheath was in use during the event.
Additional Manufacturer Narrative
On 12/28/2017, the bwi failure 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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that the catheter got stuck in a fully deflected state.No patient consequence was reported, however, the knob could be moved by the physician, but the catheter did not move with it.The returned device was visually inspected and it was found in normal conditions.Then per the event, a deflection test was performed and the catheter passed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint cannot be confirmed.Manufacturer's ref #(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: 6944871
• Report Number: 2029046-2017-01023
• Device Sequence Number: 683469
• Product Code: DRF
• UDI-Device Identifier: 10846835004960
• UDI-Public: (01)10846835004960(11)170824(17)200823(10)17725838M
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K953663
• 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,Followup,Followup

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: 08/23/2020
• Device Catalogue Number: D728260RT
• Device Lot Number: 17725838M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 09/27/2017; 09/27/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 01/03/2018; 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1