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

Model Number D134805

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

Still pending is the manufacturer record evaluation, manufactured date and the expiration date.Therefore, a supplemental 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).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the devices sterilization was compromised.It was reported that the packaging of the thermocool® smart touch® sf bi-directional navigation catheter was damaged which compromised the sterility of the device.The device was not used.There is no information how the issue was resolved.There was no report of patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The compromised sterility issue was assessed as reportable.

Manufacturer Narrative

Additional information was received on the event on december 12, 2019.There was a procedure being performed on the patient.The procedure was completed with a different catheter.There were no patient consequences.The biosense webster inc.Product analysis lab received the device for evaluation.The initial visual inspection of the product revealed no physical damage.The original box was not returned by the customer.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).

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.It was reported that the packaging of the thermocool® smart touch® sf bi-directional navigation catheter was damaged which compromised the sterility of the device.The device was not used.There was a procedure being performed on the patient.The procedure was completed with a different catheter.There were no patient consequences.The device was returned and no physical damage was observed; however, the 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 confirmed since the packaging was not returned for analysis.Manufacturer¿s reference number: pc-000584626.

• 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: 9349426
• MDR Text Key: 195388356
• Report Number: 2029046-2019-03905
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30269524L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1