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

Model Number SAT001

Device Problems Material Opacification (1426); Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 a patient underwent an atrial fibrillation (afib) ablation procedure with a smart ablate¿ irrigation tubing set and a foreign material issue occurred.It was reported that when the smart ablate¿ irrigation tubing set was opened, and was being primed, a small white foreign material (such as a fragment of something) was noticed inside the tubing.The tubing was replaced, and the issue resolved.There was no patient consequence as the issue was noticed prior device usage.

Manufacturer Narrative

On 12/14/2020, the product investigation was completed based on photographic evidence provided.It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set and a foreign material issue occurred.It was reported that when the smartablate¿ irrigation tubing set was opened and was being primed, a small white foreign material (such as a fragment of something) was noticed inside the tubing.The tubing was replaced, and the issue resolved.There was no patient consequence as the issue was noticed prior device usage.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.According to pictures provided by customer, foreign material is inside tubing.A manufacturing record evaluation was performed for the finished device ac5747712 number, and no internal action related to the complaint was found during the review.Customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.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

On 2/11/2021, 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc- (b)(4).

Manufacturer Narrative

On (b)(6)2021, the product investigation for the physical complaint device was completed.It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set and a foreign material issue occurred.It was reported that when the smartablate¿ irrigation tubing set was opened and was being primed, a small white foreign material (such as a fragment of something) was noticed inside the tubing.The tubing was replaced, and the issue resolved.There was no patient consequence as the issue was noticed prior device usage.Device evaluation details: according to pictures provided by customer, foreign material is inside tubing.The physical device was also inspected and it was found in good normal condition.Device was observed with the microscope and it was found foreign material embedded on the external part of the tubing and drip chamber.A fourier transform infrared spectroscopy (ftir) analysis was performed, overall ftir results revealed that foreign material is primarily composed of acrylate based material.Then, the foreign material was investigated by manufacturer and it was determined that the particle embedded in tubing and drip chamber are within the specified limits of allowed particles per released internal procedures.The size and quantity of particles (0.25 mm2 and 0.099 mm2) are within the allowed ranges as the size is below the 0.30 mm2 mark.Even though foreign matter was found, the complaint was not confirmed since the foreign matter was not inside the device, it was embedded on the external part of the device and the size was within the allowed ranges.A manufacturing record evaluation was performed for the finished device ac5747712 number, and no internal action related to the 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 reference number: (b)(4).

• 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): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10856058
• MDR Text Key: 216954548
• Report Number: 2029046-2020-01777
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990017/S17
• 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: 03/25/2022

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: 02/28/2021
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC5747712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 12/14/2020; 02/11/2021; 04/08/2021; 03/09/2022
• Supplement Dates FDA Received: 12/16/2020; 02/26/2021; 04/27/2021; 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2020
• 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.