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

Model Number D134805

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

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 an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and an open pouch seal issue occurred.It was reported that the packaging appeared to have already been opened and the facility was not able to use it.The catheter was replaced, and the issue was resolved.The procedure was completed without patient consequence.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and an open pouch seal issue occurred.It was reported that the packaging appeared to have already been opened and the facility was not able to use it.The catheter was replaced, and the issue was resolved.The procedure was completed without patient consequence.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection of the returned product.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.It was stated that the issue reported was related to the packaging of the thermocool® smart touch® sf bi-directional navigation catheter.Since the original package was not returned, no analysis could be performed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.In addition, a picture showing the catheter pouch was received for analysis.Damage or opening cannot be identified.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.H6. investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.  if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

The biosense webster, inc.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) per an internal review on 3-sep-2021, it was noted that the correct medical device problem code is tear, rip or hole in device packaging (a020504).Therefore, h6.Medical device problem code was updated.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12311222
• MDR Text Key: 266178670
• Report Number: 2029046-2021-01332
• 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,Followup
• Report Date: 07/19/2021

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: 05/25/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30547329M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 08/21/2021; 09/17/2021
• Supplement Dates FDA Received: 09/15/2021; 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF UNID, TC, F; THMCL SMTCH SF UNID, TC, F