MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number	D708DR002RT
Medical Device Problem Codes	Material Frayed (1262); Device Issue (2379)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.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.The device history record (dhr) for the lot number 17763237m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial flutter left (l-afl) procedure with a webster¿ electrophysiology catheter.It was reported that the catheter was not deflecting properly due to a defective puller wire.It was also reported that some of the insulation of the catheter was exposed.The catheter was replaced and the deflection issue remained.The catheter was replaced again and the issue resolved.No patient consequence was reported.The response received confirmed that the physician reported that he rubbed with his gloved finger an electrode ring on both catheters and felt sharp edges.The issue was observed prior to insertion into the body upon removal from sterile package.It was also confirmed that the insulation exposed was observed proximal to the distal pair of electrodes.The catheter was not pre-shaped.The deflection issue was assessed as not reportable.Since the catheter is unable to deflect or relax completely, the user will not be able to use the device and will have to replace it.The potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.The sharp ring edges and insulation exposed issues were both assessed as reportable malfunctions on both the webster¿ electrophysiology catheter¿s.
Additional Manufacturer Narrative
The biosense webster inc.Failure analysis lab received the device for evaluation on 4/13/2018.It was noted during the visual inspection that the returned catheter was found in good normal condition.No wires were exposed and tip was not bent.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 ref.No: (b)(4).
Additional Manufacturer Narrative
Investigation summary: it was reported that a patient underwent an atrial flutter left (l-afl) procedure with a webster¿ electrophysiology catheter.It was reported that the catheter was not deflecting properly due to a defective puller wire.It was also reported that some of the insulation of the catheter was exposed.The catheter was replaced and the deflection issue remained.The catheter was replaced again and the issue resolved.No patient consequence was reported.The response received confirmed that the physician reported that he rubbed with his gloved finger an electrode ring on both catheters and felt sharp edges.The issue was observed prior to insertion into the body upon removal from sterile package.It was also confirmed that the insulation exposed was observed proximal to the distal pair of electrodes.The catheter was not pre-shaped.The device was visually inspected and it was found in good conditions, no damage was observed.Then, deflection test was performed and it was found within specifications, the catheter was deflecting correctly.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 reference number: (b)(4).

• Brand Name: WEBSTER¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7374588
• Report Number: 2029046-2018-01358
• Device Sequence Number: 1160468
• Product Code: DRF
• UDI-Device Identifier: 10846835000269
• UDI-Public: 10846835000269
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K892265
• 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
• Report Date (Section B): 03/01/2018

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: 11/13/2020
• Device Catalogue Number: D708DR002RT
• Device Lot Number: 17763237M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 03/01/2018; 03/01/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/18/2018; 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1