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

Model Number D134805

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020, the bwi product analysis lab received the complaint device for evaluation.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 that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter, and the sealed pouch was found to be open.It was reported that the inner packaging of the thermocool® smart touch® sf bi-directional navigation catheter was found to be open when the exterior box was opened, and the catheter was removed from the exterior box.The catheter was exchanged and the issue was resolved.The case continued without any further incident.The thermocool® smart touch® sf bi-directional navigation catheter with the open pouch was not used on the patient.No further information is available.

Manufacturer Narrative

It was reported that the inner packaging of the thermocool® smart touch® sf bi-directional navigation catheter was found to be open when the exterior box was opened, and the catheter was removed from the exterior box.The thermocool® smart touch® sf bi-directional navigation catheter was not used on the patient.Device evaluation details: the device evaluation has been completed.The returned device was visually inspected and it was found in normal conditions.Then complaint reported by the customer cannot be evaluated since the original packaging was not returned for analysis.A manufacturing record evaluation was performed for the finished device 30405027m number, and no internal actions related to the reported complaint condition were identified.Complaint was not confirmed.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 SF 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: 10659229
• MDR Text Key: 210897691
• Report Number: 2029046-2020-01460
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30405027M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF BID, TC, D-F