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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a atrial flutter right (r-afl) with two (2) thermocool® smart touch® sf bi-directional navigation catheters which had sterility compromised when it was found that the sterilized plastic cover/packaging was opened.It was reported that when the box of the catheter was opened the team noticed that the sterilized plastic cover was opened.Another catheter was opened, and it was again noticed that the plastic cover was cut and opened.The procedure was delayed 5 minutes.Another catheter was used and the procedure was successfully completed.There was no patient consequences.

Manufacturer Narrative

Device investigation details: a picture of the complaint device was provided by the customer to aid in the investigation.The picture received was evaluated following biosense webster's procedures.According to pictures provided by the customer, it looks like the pouch of the catheter was cut off with a sharp object, however, this cannot be conclusively determined.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2022-01804 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # 2029046-2022-01805 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15180817
• MDR Text Key: 304729950
• Report Number: 2029046-2022-01805
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2022

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: 10/10/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30642607L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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
• Treatment: THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF BID, TC, D-F