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

Catalog Number D134805

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 11/26/2018.Initial visual analysis indicates no foreign matter was found in catheter pouch.The catheter fell on the floor and the rocker arm broke off, however, the rest of the catheter looks normal.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) for the lot number 30073299l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Initial reporter phone: (b)(6).Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter and foreign matter was identified within the packaging prior to being used on the patient.Upon opening the sterile packaging containing, several staff members observed a ¿black foreign matter¿ described as ¿half of a grain of rice¿ located inside the packaging.Upon removing the catheter from the packaging, the foreign material fell out.They did not used the catheter, instead, it was exchanged for another catheter of a different lot and the procedure was completed without patient consequence.The reported event of foreign material inside the packaging has been assessed as mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter and foreign matter was identified within the packaging prior to being used on the patient.Product evaluation details: product evaluation has been completed.The pouch was inspected and no foreign material was observed, during inspection, the catheter fell out and the rocker arm broke.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 was not confirmed.No foreign material was observed.Manufacturer¿s ref #: (b)(4).

• 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: 8107486
• MDR Text Key: 129185745
• Report Number: 2029046-2018-02365
• 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
• Report Date: 10/29/2018

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: 06/17/2019
• Device Catalogue Number: D134805
• Device Lot Number: 30073299L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/27/2018
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1