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

Model Number SAT001

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The bwi 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.A manufacturing record evaluation was performed for the finished device ac5758056 number, and no internal action related to the reported complaint was found during the review.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 an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set, and an open pouch seal issue was encountered.It was reported that when first opening the packaging of the smartablate¿ irrigation tubing set, it was noticed that the seal of the package was already opened.The staff member opened it more after realizing it was already cracked.The product was not used, the irrigation tubing was replaced, and the issue was resolved.The procedure continued without further issues.There was no patient consequence.

Manufacturer Narrative

On (b)(6)2020, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set, and an open pouch seal issue was encountered.It was reported that when first opening the packaging of the smartablate¿ irrigation tubing set, it was noticed that the seal of the package was already opened.The staff member opened it more after realizing it was already cracked.The product was not used, the irrigation tubing was replaced, and the issue was resolved.The procedure continued without further issues.There was no patient consequence.Device evaluation details: according to pictures provided by customer, shows tubing set in original packaging.The adhesive seal of the packaging is rolled down such that the seal to the packaging is open.Per additional information received from customer, the staff member opened it more after realizing it was already cracked.The unit was inspected prior to leave the facility as there are process inspections.Therefore, an external damage could be caused the seal opening but the root cause cannot be conclusively determined.Additionally, the catheter was visually inspected and it was found in normal conditions.Then per the reported event, no tests were performed since the original packaging was not returned for analysis.However, the unit was inspected prior to leaving the facility per the functional tests and inspections at control points based on the process.A manufacturing record evaluation was performed and no internal action related to the reported complaint was found during the review.The customer complaint cannot be confirmed.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 ref.# (b)(4) per internal review on (b)(6)2022, the manufacturing site name and address have been updated to reflect lake region medical.All the appropriate fields in section g.All manufacturers have been updated accordingly.

• Brand Name: SMARTABLATE¿ IRRIGATION TUBING SET
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): LAKE REGION MEDICAL; 31-c butterfield trail; el paso TX 91706
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10314532
• MDR Text Key: 200457159
• Report Number: 2029046-2020-00925
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990017/S17
• 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,Followup
• Report Date: 06/09/2022

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: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC5758056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 07/29/2020; 06/08/2022
• Supplement Dates FDA Received: 08/21/2020; 06/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2019
• 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: SMARTABLATE IRR TUBE SET.