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

Model Number D134801

Device Problems Partial Blockage (1065); Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure for right atrial tachycardia with a thermocool® smart touch® sf bi-directional navigation catheter where blood clot occurred.One hour after the catheter was inserted into the patient¿s body, thrombus adhered to the tip of the catheter.The thermocool® smart touch® sf bi-directional navigation catheter was changed, because the blood clot was removed but it was not perfused from the tip.The issue of a blood clot has been assessed as mdr reportable.The report of inadequate irrigation is not mdr reportable since intermittent or low irrigation is highly detectable by the physician.The most likely consequence is an intraprocedural delay the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.

Manufacturer Narrative

It was reported that a patient underwent cardiac ablation procedure for right atrial tachycardia with a thermocool® smart touch® sf bi-directional navigation catheter where blood clot occurred.One hour after the catheter was inserted into the patient¿s body, thrombus adhered to the tip of the catheter.The thermocool® smart touch® sf bi-directional navigation catheter was changed, because the blood clot was removed but it was not perfused from the tip.On 2/3/2021, additional information was received indicating that no error messages were observed.No temperature issues were reported.Device evaluation details: on 1/27/2021, the bwi product analysis lab received the complaint device for evaluation and the evaluation has been completed.The device was visually inspected, and no physical damage was found.No thrombus was observed.Per the event information, generator test was performed, and the device was found working within specifications.In addition the irrigation of the device was tested with the cool flow pump and it was found working correctly; no obstructions were found.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was not confirmed since the device was working correctly.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).It was noticed the h6.Medical device problem code of a030202 (coagulation in device or device ingredient) was inadvertently omitted from the 3500a initial medwatch report.

Manufacturer Narrative

The product investigation was re-open to include details that clarify ¿no char was observed on the device¿ during visual analysis/inspection of the returned device.Manufacturer¿s ref # (b)(4) initially this event was assessed as mdr reportable for a blood clot/thrombus issue.During review on (b)(6) 2021, a correction was noted to the assessment as this event should have been assessed as char which is not mdr reportable.Char is a physical phenomenon of radio frequency energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.Therefore, the h6.Medical device problem code of ¿device contamination with body fluid¿ is being used to represent the issue.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 11085122
• MDR Text Key: 232588297
• Report Number: 2029046-2020-01998
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• 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: 12/01/2020

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: 06/16/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30392071M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/27/2021; 05/20/2021
• Supplement Dates FDA Received: 02/19/2021; 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1