MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMRTTCH,BI,NAV,TC,D-F,C3; 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 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi 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.Manufacture ref no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for paroxysmal vein isolation (pvi) with a thermocool® smart touch¿ bi-directional navigation catheter, and an inadequate irrigation issue occurred.The physician reported blocked irrigation holes during ablation.A flush bolus of 60 ml/min did not solve the issue.Catheter replacement resolved the issue.No adverse patient consequences were reported.The inadequate irrigation issue has been assessed as not reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This event is being reported because the bwi product analysis lab (pal) received the device for evaluation on (b)(6) 2018, and found some foreign white material inside the irrigation hole occluding the tip dome.The observed foreign material has been assessed as mdr reportable.The awareness date has been reset to (b)(6) 2018.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for paroxysmal vein isolation (pvi) with a thermocool® smart touch¿ bi-directional navigation catheter, and an inadequate irrigation issue occurred.The investigational analysis completed 2/28/2019.The device was visually inspected and some white material was observed inside the irrigation holes.During the second inspection, the material was not observed.This could be related to the decontamination process.Irrigation testing was performed and it was found within specifications.The catheter was irrigating correctly.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device and no non-conformances related to the reported complaint condition were identified.The customer complaint cannot be confirmed.The white material observed inside the irrigation holes is foreign material and is not part of the device.However, this material cannot be investigated since it was lost due to the decontamination process.The root cause of the foreign material cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacturer ref no: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for paroxysmal vein isolation (pvi) with a thermocool® smart touch¿ bi-directional navigation catheter, and an inadequate irrigation issue occurred.Additional information was received on 1/14/2019, indicating no pump error was observed.The irrigation issue was detected while flushing the catheter before patient insert.On 1/28/2019, a manufacturing record evaluation was performed for the finished device 30073980m number, and no non-conformances related to the reported complaint condition were identified.Manufacture reference no:(b)(4).

• Brand Name: THMCL SMRTTCH,BI,NAV,TC,D-F,C3
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8240910
• MDR Text Key: 133380980
• Report Number: 2029046-2019-02557
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2018

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: 06/19/2019
• Device Catalogue Number: D132705
• Device Lot Number: 30073980M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 01/14/2019; 02/28/2019
• Supplement Dates FDA Received: 02/06/2019; 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1