MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895); Sharp Edges (4013)

Patient Problem Hematoma (1884)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Note: although patient code is coded, it was assessed as a patient event non-serious and should not be considered to be mdr reportable.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab identified a hole on the catheter sleeve exposing the internal wires.It was initially reported by the customer that during the procedure, there was difficulty with the manipulation of the thermocool® smart touch¿ electrophysiology catheter and there was a kink at the proximal end of the catheter (just distal to handle).Removal of ablation catheter was difficult, and it was discovered there was a further kink in the distal end to the femoral sheath within the right femoral artery.The thermocool® smart touch¿ electrophysiology catheter and sheath were removed successfully (sheath had concertina but did not shear).A moderate sized groin hematoma was observed following this removal.Procedure was abandoned and patient admitted for observation.Additional information received states the patient underwent computed tomography (ct) to confirm there was no injury from the device and then was admitted for observation.The sheath used was a terumo 8fr radifocus.Based on the information provided by the customer, the issue of ¿resistance with the sheath¿ and the ¿kinks¿ have been assessed as not mdr reportable since the potential that these could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Additionally, the groin hematoma was assessed as not mdr reportable since the event was not life threatening, did not result in permanent impairment of a body function or permanent damage to a body structure; or did not necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.On 4/14/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.On 4/14/2020, visual inspection found the shaft is kinked approximately 81 cm, 89 cm, and 112 cm cm from distal tip.On 4/16/2020, it was found that approximately 112 cm from the distal tip the catheter sleeve has a hole exposing the internal wires.The issue of ¿kinks¿ was assessed as not mdr reportable, however, the issue of a ¿hole exposing internal wires¿ was assessed as an mdr reportable malfunction.On 04/27/20, it was also found that electrodes #4 and #5 were deformed and had sharp edges.These findings were also assessed as mdr reportable malfunctions.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 4/16/2020 and reassessed this complaint as mdr reportable.

Manufacturer Narrative

It was initially reported by the customer that during the procedure, there was difficulty with the manipulation of the thermocool® smart touch¿ electrophysiology catheter and there was a kink at the proximal end of the catheter (just distal to handle).Removal of ablation catheter was difficult, and it was discovered there was a further kink in the distal end to the femoral sheath within the right femoral artery.The thermocool® smart touch¿ electrophysiology catheter and sheath were removed successfully (sheath had concertina but did not shear).A moderate sized groin hematoma was observed following this removal.Procedure was abandoned and patient admitted for observation.Based on the information provided by the customer, the issue of ¿resistance with the sheath¿ and the ¿kinks¿ have been assessed as not mdr reportable since the potential that these could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Additionally, the groin hematoma was assessed as not mdr reportable since the event was not life threatening, did not result in permanent impairment of a body function or permanent damage to a body structure; or did not necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.On 4/14/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.On 4/14/2020, visual inspection found the shaft is kinked approximately 81 cm, 89 cm, and 112 cm cm from distal tip.On 4/16/2020, it was found that approximately 112 cm from the distal tip the catheter sleeve has a hole exposing the internal wires.The issue of ¿kinks¿ was assessed as not mdr reportable, however, the issue of a ¿hole exposing internal wires¿ was assessed as an mdr reportable malfunction.On 04/27/20, it was also found that electrodes #4 and #5 were deformed and had sharp edges.These findings were also assessed as mdr reportable malfunctions.On 5/5/2020, further inspection of the complaint device revealed a foreign white material was found on electrode #5.The foreign material was assessed as an mdr reportable malfunction.Device evaluation details: the device evaluation has been completed.The device was visually inspected and several damages were found.The shaft was kinked, approximately 112 cm from distal tip the sheath sleeve has a hole exposing the internal wires.A second closer inspection was performed, and the electrode was found lifted with a ¿white¿ foreign material underneath the electrode.The electrode was lifted and no polyurethane (pu) was observed at the margins.On 5/21/2020, a fourier transform infrared spectroscopy test (ftir) was performed on a sample of the foreign material and the results showed that white particle is primarily composed of a polyethylene - based material with a second component, barium sulfate.This material composite is widely used as radio pacifier within the medical device industries.However, source of origin remains unknown.The ftir results confirms the foreign material continues to be deemed mdr reportable.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause kinked shaft and the hole 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.The root cause of the polyethylene under the ring and the ring damage could be related to the friction of the catheter with the sheath during procedure, however, this cannot be conclusively determined.The customer had also provided pictures of the reported issue for assessment.According to pictures provided by customer, two kinks were observed on catheter shaft.Based on the pictures alone, the customer¿s complaint was also confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref : (b)(4).

Manufacturer Narrative

On (b)(6) 2020, further inspection of the complaint device revealed a foreign white material was found on electrode #5.The sample was sent to fourier transform infrared spectroscopy to verify the composition.With the available information the material will be assessed as an mdr reportable malfunction.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10016326
• MDR Text Key: 202238486
• Report Number: 2029046-2020-00589
• 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: 03/26/2020

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: 11/14/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30317242L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 04/30/2020
• Supplement Dates Manufacturer Received: 05/05/2020; 06/17/2020
• Supplement Dates FDA Received: 05/21/2020; 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO 8FR RADIFOCUS SHEATH