MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE¿ IRRIGATION TUBING SET; CARDIAC ABLATION SYSTEM IRRIGATION TUBING SET

Catalog Number UNK_SMARTABLATE PUMP TUBING

Device Problem Material Integrity Problem (2978)

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

Event Date 12/20/2021

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 reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent atrial fibrillation (afib) ablation procedure with a unk_smartablate pump tubing.There was a tubing problem during the procedure.It was reported that the smarttouch sf catheter was not irrigating properly.The catheter was flushed, without resolution.The caller reported that when coming on ablation, it was noticed that the temperature would immediately rise, and exceed the maximum temperature setting, cause ablation to cut off.The smarttouch sf catheter was removed from the body, and flushed, but the catheter was still not irrigating properly.The smarttouch sf catheter was replaced, and the issue still persisted.The reporter then checked the irrigation line, and it was noticed that the irrigation line or tubing had been "pulled up" into the smartablate pump clear plastic housing, causing the irrigation issue.The irrigation tubing was straightened out properly, and the issue had resolved.The procedure continued.No patient consequences were reported.Tubing problem during procedure is mdr-reportable.

Manufacturer Narrative

On 26-mar-2022, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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: SMARTABLATE¿ IRRIGATION TUBING SET
• Type of Device: CARDIAC ABLATION SYSTEM IRRIGATION TUBING SET
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): LAKE REGION MEDICAL; 31-c butterfield trail; el paso TX 79906
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13238070
• MDR Text Key: 289180889
• Report Number: 2029046-2022-00072
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMARTABLATE PUMP TUBING
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THERMOCOOL SMARTTOUCH