MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number D135303

Device Problems Entrapment of Device (1212); Failure to Unfold or Unwrap (1669); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

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.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.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(6).Manufacturer's ref.No: (b)(4).

Event Description

It was reported a patient underwent a procedure with webster¿ electrophysiology catheter wherein the catheter tip became knotted, entrapped within the patient¿s body and then the catheter tip detaching within the patient¿s body.Upon insertion of the webster¿ electrophysiology catheter into the patient a loop formed within the inferior vena cava (ivc) and could not be unlooped.They tried to withdraw the webster¿ electrophysiology catheter using the bifurcation to unloop, however, the loop pulled down into the left femoral vein and then couldn't move the lower end of the loops position.The physician completed the procedure and hoped the change in temperature of the catheter within the body would allow it to be moved so the catheter was then pulled down and it was pulling back with resistance.At this stage physician felt reasonable to continue pulling back it order to attempt to straighten the loop out.Unfortunately, the distal end of the catheter then snapped resulting in a detached tip and internal components of the catheter being exposed.Intervention radiologist used a large sheath and a snare to successfully remove the part from the patient.There was no patient consequence as the catheter was successfully removed.A cordis, avanti 6¿ french introducer sheath was used.The events of knotted catheter, detached catheter and device entrapment are mdr reportable malfunctions.

Manufacturer Narrative

On 1/7/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Upon receipt, the biosense webster inc.Product analysis lab was able to verify the product identify.Appropriate fields have been updated.The initial visual analysis identified, ¿distal end of catheter has been detached.Internal parts are exposed.¿ the finding was reviewed and assessed as not mdr reportable because the catheter tip is cut, which is a common practice in some hospitals, thus, the exposed wires are not relevant to the procedure and the damage was inflicted after the catheter left the patient.On 1/23/2019, further product evaluation including a scanning electron microscope (sem) analysis was performed.The scanning electron microscope (sem) test results showed ¿evidence of mechanical damage, torsion, and ductile dimples on the sample surface.Mechanical damage and stretching could be related to these surface characteristics.¿ these findings have been reviewed and assessed as mdr reportable since the integrity of the catheter is compromised.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.The following fields are being updated based on verified product identity: brand name changing from ¿webster¿ electrophysiology catheter¿ to ¿webster cs catheter with auto id technology.¿ common device name changing from ¿electrode, pacemaker, temporary¿ to ¿catheter, electrode recording, or probe, electrode recording.¿.Procode changing from ¿ldf¿ to ¿drf¿.The following fields have been populated based on verified product identity: catalog d135303; lot 30095577m; expiration date 7/30/2021; unique identifier (udi) (b)(4); pma/510(k) k080425; device manufacture date 7/31/2018; manufacturer's ref # (b)(4).

Manufacturer Narrative

It was reported a patient underwent a procedure with webster¿ electrophysiology catheter wherein the catheter tip became knotted, entrapped within the patient¿s body and then the catheter tip detaching within the patient¿s body.On 1/31/2019, a manufacturing record evaluation was performed for the finished device 30095577m number, and no non-conformances related to the reported complaint condition were identified.Device evaluation details: on 2/7/2019, the device evaluation was been completed.The device was inspected and the distal catheter was found detached with internal parts exposed, also, the shaft was found twisted.Then, the catheter outer diameter was measured and it was found within specification.Additionally, a scanning electron microscope (sem) testing was performed on the damage area and the results showed evidence of mechanical damage, torsion, and ductile dimples on the sample surface.Mechanical damage and stretching could be related to these surface characteristics, however the exact cause of the separation could not be conclusively determined.No other anomalies were observed.The customer complaint was confirmed.The root cause of the damage on the tip its related to the manipulation of the device during the procedure since it was pulled back and then the tip snapped.In addition, there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s ref # (b)(4).

• Brand Name: WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8191736
• MDR Text Key: 132062453
• Report Number: 2029046-2018-02486
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2021
• Device Catalogue Number: D135303
• Device Lot Number: 30095577M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 01/07/2019; 01/31/2019
• Supplement Dates FDA Received: 01/29/2019; 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1