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

Model Number SAT001

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

Still pending is the manufacturer record evaluation.Therefore, a supplemental report will be submitted.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 foreign material was found inside the packaging.It was reported by the caller that when they opened the packaging for the smartablate¿ irrigation tubing set, they found a hair in the package.The tubing was replaced and the procedure was continue.There was no patient consequence.The issue of foreign material within the packaging has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

Correction: on 7/9/2019, it was noticed that the following information was omitted from the 3500a initial mdr submitted to fda.It was noticed that the customer provided additional information on 6/26/2019 indicating the foreign material observed within the packaging (described as a hair) was observed outside of the tubing and loose.It was confirmed that the tubing was never used on the patient.Manufacturer's ref # pc-(b)(4).

Manufacturer Narrative

On 6/26/2019, a picture of the complaint product was provided by the customer.The image has been reviewed by biosense webster inc.And confirmed a fibrous material was in the package.On 7/23/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis found the appearance of fiber-like material.It was noted that the packaging was not sealed upon receipt.The file continues to be mdr reportable for the foreign material within the package as originally reported.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set and foreign material was found inside the packaging.It was reported by the caller that when they opened the packaging for the smartablate¿ irrigation tubing set, they found a hair in the package.The tubing was replaced and the procedure was continue.There was no patient consequence.Device investigation details: the device investigation has been completed.The investigation was performed by the device manufacturer.The manufacturer confirmed the hair in the package.The manufacturer could not determine if the hair was from manufacturing.However, the manufacturer identified that several gaps in their system and opened an internal corrective action.While the manufacturer confirmed the hair, the manufacturer could not verify if the hair came from manufacturing because the device pouch was opened.A manufacturing record evaluation was performed for the finished device and no internal action related to the reported complaint condition were identified.The customer also provided a photo of the complaint device/issue which presented the appearance of fiber-like material found inside of packaging.The picture confirmed that a fibrous material was in the package.Manufacturer¿s ref # (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: 8747130
• MDR Text Key: 149804107
• Report Number: 2029046-2019-03371
• 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,Followup,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC4665907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2019
• 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