MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number BDI35FJRT

Device Problems Device Contamination with Chemical or Other Material (2944); Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2017

Event Type  malfunction  

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.Concomitant products: st.Jude medical sl3 8fr sheath.(b)(4).

Event Description

It was reported that a patient underwent a procedure for atrial flutter with an ez steer thermocool sf non-navigational catheter where foreign matter was found on the catheter tip.During the procedure, erratic impedance values were noted, prompting the physician to check the catheter tip.The catheter was removed from the sheath, and a long piece of foreign material was observed attached to the tip.The physician attempted to remove it by pulling, but was unable to do so.For this reason, the physician believes that the foreign material was part of the catheter itself.The catheter was replaced, and the case was successfully completed.No patient consequences were reported.No wires were exposed.The deflection knob was still operable.No difficulty was noted during the removal of the catheter from the sheath.A st.Jude medical sl3 8fr sheath was in use.Foreign material on the usable length of the catheter presents a possible risk to the patient, making this event mdr reportable.

Manufacturer Narrative

On 11/15/2017, 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).

Manufacturer Narrative

It was reported that a patient underwent a procedure for atrial flutter with an ez steer thermocool sf non-navigational catheter where foreign matter was found on the catheter tip.During the procedure, erratic impedance values were noted, prompting the physician to check the catheter tip.The catheter was removed from the sheath, and a long piece of foreign material was observed attached to the tip.The physician attempted to remove it by pulling, but was unable to do so.For this reason, the physician believes that the foreign material was part of the catheter itself.The catheter was replaced, and the case was successfully completed.No patient consequences were reported.No wires were exposed.The deflection knob was still operable.Returned product evaluation: the returned device was visually inspected and whitish material was found on the catheter tip.Then, the catheter outer diameter was measured and it was found within specifications.Per the foreign material observed, a fourier transform infrared spectroscopy test (ftir) was performed and the results showed that the foreign material has a biological-base material presumably human tissue.Then, the catheter was tested for electrical performance and stockert compatibility and it was found within specifications.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 was confirmed.Based on available analysis finding results, the failure mode does not appear to be caused by any internal bwi processes, it could be related to the procedure.(b)(4).

• Brand Name: THERMOCOOL SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7010461
• MDR Text Key: 92325937
• Report Number: 2029046-2017-01116
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002843
• UDI-Public: (01)10846835002843(11)170727(17)200630(10)17709862L
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: BDI35FJRT
• Device Catalogue Number: BDI35FJRT
• Device Lot Number: 17709862L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 10/18/2017; 10/18/2017
• Supplement Dates FDA Received: 11/16/2017; 02/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1