MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D132704

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the complaint device for evaluation.Initial visual analysis observed there was no visual damage or anomalies.No packaging was returned.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.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 flutter right (r-afl) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a sterility issue was encountered.It was reported that after opening the catheter packaging, it was discovered that the pouch seal for the catheter, inside the box, was already opened, and the sterility was compromised (caller noted that there appeared to be no visible damage to the exterior box).The thermocool® smart touch¿ bi-directional navigation catheter was not used on the patient.The catheter was replaced and the issue was resolved.The procedure was continued.There was no report of patient consequence.

Manufacturer Narrative

It was reported a patient underwent an atrial flutter right (r-afl) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a sterility issue was encountered.It was reported that after opening the catheter packaging, it was discovered that the pouch seal for the catheter, inside the box, was already opened, and the sterility was compromised (caller noted that there appeared to be no visible damage to the exterior box).The thermocool® smart touch¿ bi-directional navigation catheter was not used on the patient.Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found in good conditions, no packaging returned.The pouch seal opened reported by the customer cannot be evaluated since the original packaging was not returned for analysis.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint cannot be evaluated.The root cause of the seal opened failure cannot be related to the manufacture process since there is evidence that the device was manufactured in accordance with documented specification and procedures.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9824123
• MDR Text Key: 195580448
• Report Number: 2029046-2020-00394
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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: 03/05/2020
• Device Model Number: D132704
• Device Catalogue Number: D132704
• Device Lot Number: 30185074M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.