MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE IRRIGATION TUBING SET; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number SAT001

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product 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.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 atrial fibrillation (afib) with a smartablate¿ irrigation tubing set where an open pouch seal issue occurred.It was reported that the smartablate¿ irrigation tubing set appeared to have already been opened.A new set was opened to complete the procedure.

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).During an internal review on 14-sep-2021, it was noted that the previously reported code of ¿delivered as unsterile product (a020701¿, under h6.Medical device problem code, is incorrect.The correct code is ¿tear, rip or hole in device packaging (a020504)¿.Therefore, h6.Medical device problem code has been updated.The awareness date is 14-sep-2021.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 2-aug-2021.The device evaluation was completed on 6-aug-2021.It was reported that a patient underwent an atrial fibrillation (afib) with a smartablate¿ irrigation tubing set where an open pouch seal issue occurred.It was reported that the smartablate¿ irrigation tubing set appeared to have already been opened.A new set was opened to complete the procedure.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the smartablate¿ irrigation tubing set.The device was returned without its original package; therefore, test cannot be performed due to the device returned condition.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.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 PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12271341
• MDR Text Key: 264956679
• Report Number: 2029046-2021-01260
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• Combination Product (y/n): N
• PMA/PMN Number: P990017/S17
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2021

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: 03/31/2022
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC6380114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 08/06/2021; 09/14/2021
• Supplement Dates FDA Received: 08/31/2021; 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT FAST CATH SR0- 8.5F; PENTARAY NAV ECO 7FR, D, 2-6-2; PENTARAY NAV ECO 7FR, D, 2-6-2; UNKNOWN BRAND IRRIGATION TUBING SET