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 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 30149268l number, and no internal actions were found during the review.Manufacturing ref # (b)(4).

Event Description

It was reported a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter wherein a foreign material issue occurred.It was reported that while opening the package of the thermocool® smart touch® sf bi-directional navigation catheter, the nurse noticed small particles falling out of the package.The nurse described hearing particles or something that was lose but didn¿t see it.No patient consequence was reported.The customer indicated they could not identify the particles, but it seemed to be related to the handle pins since the catheter could not be connected to the catheter cable.It seemed like the connector pins were not straight.The thermocool® smart touch® sf bi-directional navigation catheter was never used on the patient.The issue of connector pins being bent or broken is not mdr reportable since having connector pins bent or broken, the device can¿t be used.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event is remote.The issue of ¿foreign material¿ reported by the customer is mdr reportable.

Manufacturer Narrative

On 5/29/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis observed the connector pins on the returned device were bent.The pouch that the device was returned in was also checked for anomalies; none were found.These findings have been assessed as not mdr reportable since the potential that the bent pins could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This complaint remains mdr reportable per event description.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

It was reported a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter wherein a foreign material issue occurred.It was reported that while opening the package of the thermocool® smart touch® sf bi-directional navigation catheter, the nurse noticed small particles falling out of the package.It seemed to be related to the handle pins since the catheter could not be connected to the catheter cable.It seemed like the connector pins were not straight.Device evaluation details: the device was inspected and several pins were observed bent also, no anomalies or particles were observed on the returned pouch.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint regarding the bent pins was confirmed.However, the customer complaint regarding the particles on the package was not confirmed.In addition, the customer clarified that they don't have any foreign material.The root cause of the connector pins bent cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure.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: 8508668
• MDR Text Key: 145960162
• Report Number: 2029046-2019-02973
• 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: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2019
• Device Catalogue Number: D134805
• Device Lot Number: 30149268L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1