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

Catalog Number D132705

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on (b)(6) 2018.It was noted that the customer did not return the original packaging.Only returned the label from the pouch.The returned catheter looked to be in normal condition.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.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for left atrial tachycardia with a thermocool smart touch bi-directional navigation (stsf) catheter and a foreign material inside the packaging, outside of spec issue occurred.No adverse patient consequences were reported.The foreign material inside the packaging, outside of spec issue has been assessed as mdr reportable.Prior to the procedure, a foreign object described as 1.5mm, black, and flat was found inside the catheter packaging, calling into question the sterility of the product.The stsf catheter was replaced and the procedure continued without incident.Multiple attempts have been made to obtain clarification.However, no further information has been made available.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for left atrial tachycardia with a thermocool® smart touch¿ bi-directional navigation (stsf) catheter.Prior to the procedure, a foreign object was found inside the catheter packaging questioning the sterility of the product.Another catheter was opened and replaced, and the case continued without incident.The investigational analysis completed on (b)(6) 2018.The device was visually inspected and it was found in good conditions.No failure analysis was performed since the customer did not return the packaging.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint cannot be confirmed.Manufacture reference no: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 8003415
• MDR Text Key: 126233301
• Report Number: 2029046-2018-02206
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

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: 04/05/2019
• Device Catalogue Number: D132705
• Device Lot Number: 30037133M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 10/30/2018
• Supplement Dates FDA Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1