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

Model Number D134702

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, pictures were provided by the customer.Evaluation is still in progress.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter where an open pouch seal issue occurred.Before the operation, there was a small cut in the catheter package and it was not sterile anymore.There was no report of patient consequence.The cardboard box was disposed of.The primary packaging and catheter will be returned.The event was assessed as an mdr reportable open pouch seal issue.

Manufacturer Narrative

H6. investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.  the investigation summary was completed on 2/5/2021.It was reported that a patient underwent cardiac ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter where an open pouch seal issue occurred.Before the operation, there was a small cut in the catheter package and it was not sterile anymore.There was no report of patient consequence.The cardboard box was disposed of.The primary packaging and catheter will be returned.An analysis was performed on the picture that was provided by the customer.The picture is not clear, the photo does not provide sufficient information related to the reported event and therefore, no result can be obtained from it.The customer complaint cannot be confirmed.The product analysis was performed as appropriate in order to find root cause of the complaint.The catheter was inspected and it was found in normal conditions.The customer did not return the original package/pouch.Since the issue is related to this, no analysis could be performed.All units are inspected prior leaving the facilities to avoid this type of damage.The issue could be related to product handling during shipping but this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device, and no internal action related to the reported complaint condition were identified.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

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: (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH SF UNI-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: 11152915
• MDR Text Key: 255325275
• Report Number: 2029046-2021-00032
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2021
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30452311L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1