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

Model Number D134805

Device Problems Coagulation in Device or Device Ingredient (1096); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2020

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation.Upon initial inspection, the bwi pal found a kink in the shaft with reddish- brown material in the catheters pebax.No external components were observed.The observed kink and reddish material has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.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.A manufacturing record evaluation was performed for the finished device and no internal actions were found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a thrombus issue occurred.After the thermocool® smart touch® sf bi-directional navigation catheter was inserted, right before ablation was conducted, the impedance value was high.The catheter was removed from the patient¿s body and thrombus was found adhered.The catheter was replaced, and the issue resolved.The procedure was completed without patient consequences.The observed high force has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The observed thrombus issue has been assessed as an mdr reportable malfunction.Multiple attempts were made to obtain clarification regarding this event.However, no response was received.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

The product investigational analysis completed 5/29/2020.The device was visually inspected, and a kink in the shaft and reddish/brown material in the distal tip was found.A second closer inspection was performed and a kink in the shaft and reddish material was noticed inside the pebax.On (b)(6) 2020, scanning electron microscope (sem) analysis was performed and a hole at the pebax was found.The observed whole has been assessed as an mdr reportable malfunction.Per the event, the catheter was tested for stockert compatibility and it was found within specifications.A manufacturing record evaluation was performed and no non-conformances related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the damage on pebax 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, however, this cannot be conclusively determined.The bent shaft could be related to the handling of the device during shipment.Manufacture reference no: (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: 9983290
• MDR Text Key: 201945740
• Report Number: 2029046-2020-00572
• 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: 03/25/2020

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: 11/12/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30313865M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/21/2020
• Supplement Dates Manufacturer Received: 05/14/2020
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1