MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D132705

Device Problems Insufficient Cooling (1130); Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Event year provided 2021.Medical device problem code of ¿appropriate term/code not available¿ represents "patient event non serious" for the absence of treatment issue.Initial reporter phone: (b)(6).The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and foreign material on the usable length of the catheter issue was reported.First case abandonment, the cool flow tubing had disconnected from the catheter and thus got a hi temperature alarm.They wanted to withdraw the catheter and check the tip but the catheter would not pull back in the sheath.The case was stopped upon removal of catheter and sheath as a small burr of plastic was noted on the catheter.The case was canceled.No patient consequences were reported additional information was received.The patient was under general anesthesia for 45 minutes.Transseptal puncture was performed x 2 prior to the case cancellation.The physician did not provide a causality opinion for the cause of this adverse event.There is no information about the hospitalization.The sheath used was an abbott 8.5 long.There was no occlusion when irrigating the sheath.The sheath was not narrowed, partially blocked or completely blocked.The catheter was not without force to be able to be moved through the sheath.There was material observed on the usable length of catheter, stuck to the tip of the catheter.The catheter pebax was not damaged.The high temperature issue was assessed as not mdr reportable.Since the user-defined cut-off was not exceeded, the potential that it could cause or contribute to a death, serious deterioration in state of health, or other significant adverse event, was remote.The resistance with sheath issue was assessed as not mdr reportable.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury was remote.The foreign material on the usable length of the catheter was assessed as mdr reportable.The absence of treatment was assessed as not mdr reportable.It was not life threatening.Did not result in permanent impairment of a body function or permanent damage to a body structure; or did not necessitate medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 12-aug-2021.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Initially reported non bwi-abbott 8.5 fr sheath as a concomitant product.However, additional information received on 18-aug-2021 provided a correction to the sheath used.The sheath used was pref.Guiding sheath w/mult.Crv / 301803m.Therefore, updated the ¿d10.Concomitant medical products and therapy dates¿ section.On 26-aug-2021 additional clarification was received stating the pref.Guiding sheath w/mult.Crv / 301803m was the sheath used in which the catheter was stuck.There was no error that was shown by the system or failure related to this product.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) the 3500a follow-up #1 reported in "h10.Additional manufacturer narrative" that the bwi product analysis lab received the device for evaluation on 12-aug-2021.However, during an interview on 09-sep-2021, noted a correction as d9.Is device returned to manufacturer?, d9.Date device returned to manufacturer and d9.Device available for evaluation? fields were not processed.Therefore, these fields have been completed.

Manufacturer Narrative

H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.First case abandonment, the cool flow tubing had disconnected from the catheter and thus got a hi temperature alarm.They wanted to withdraw the catheter and check the tip but the catheter would not pull back in the sheath.The case was stopped upon removal of catheter and sheath as a small burr of plastic was noted on the catheter.The case was canceled.No patient consequences were reported.Additional information was received.The patient was under general anesthesia for 45 minutes.Transseptal puncture was performed x 2 prior to the case cancellation.The physician did not provide a causality opinion for the cause of this adverse event.There is no information about the hospitalization.The sheath used was an abbott 8.5 long.There was no occlusion when irrigating the sheath.The sheath was not narrowed, partially blocked or completely blocked.The catheter was not without force to be able to be moved through the sheath.There was material observed on the usable length of catheter, stuck to the tip of the catheter.The catheter pebax was not damaged.The investigation was completed on 29-sep-2021.An analysis was performed on the pictures that were provided by the customer.According to the pictures, foreign matter was observed on the tip.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and a generator-flow evaluation of the returned device.Visual analysis of the returned sample revealed a foreign material under the ring, the ring appears slightly lifted no other anomalies were observed on the smart touch bidirectional catheter.All units are inspected prior leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.Visual test was performed, and foreign white material was observed under the ring, the ring appears slightly lifted.The sample was sent to the laboratory for analysis, the fourier transform infrared spectroscopy (ft-ir) revealed that white foreign particle is primarily composed of a polyethylene ¿ based material with a second component, barium sulfate, this composite material is widely used as radio pacifier along medical device industries; however, the source of origin remains unknown.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The catheter was tested for generator-flow-outer diameter test and it was found within specifications.No issues were observed.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The root cause of foreign white material could be related with the handling of the device during the procedure.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

In the 3500a follow-up #2 it was reported that the ¿concomitant product¿ sheath used was the ¿pref.Guiding sheath w/mult.Crv¿.However, additional information was received on 08-nov-2021 stating that the sheath used was a "non bwi-abbott sheath" and not the bwi ¿pref.Guiding sheath w/mult.Crv¿.Therefore, processed d10.Concomitant medical products and therapy dates section.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: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12257200
• MDR Text Key: 264959836
• Report Number: 2029046-2021-01223
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2022
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30541802M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NON BWI-ABBOTT 8.5 FR SHEATH.; NON BWI-ABBOTT SHEATH.; PREF.GUIDING SHEATH W/MULT.CRV.; UNK_COOLFLOW TUBING SET.