MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133605IL

Device Problems Contamination /Decontamination Problem (2895); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found white material under ring #1.Initially, it was reported that during the procedure, the catheter could not deflect to specification.A second catheter was used to complete the operation.No adverse patient consequences were reported.The observed deflection issue 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.On 12/19/2019, the bwi pal received the device for evaluation.Upon initial visual inspection, white material was observed underneath ring 1 on the proximal side.The observed foreign material has been assessed as an mdr reportable malfunction.The awareness date has been reset to 12/19/2019.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found white material under ring #1.On 1/15/2020, the biosense webster inc.(bwi) product analysis lab (pal) performed fourier transform infrared spectroscopy (ftir) testing.Results revealed the white particle observed under ring#1, is primarily composed of a polyethylene-based material with a second component; barium sulfate.This material composite is widely used as radio pacifier along medical device industries.However, the source of origin remains unknown.These findings coincide with what was initially reported.Further analysis was then performed and on 1/30/2020, the bwi pal observed ring#1 lifted with no polyurethane was observed at the margins of the ring.The observed foreign material and lifted ring have been assessed as mdr reportable malfunctions.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 reference no: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found white material under ring #1.Initially, it was reported that during the procedure, the catheter could not deflect to specification.The investigational analysis completed at 2/24/2020.The device was visually inspected, and material was found underneath the ring.A second closer inspection was performed.Foreign white material was found at the ring.The ring was lifted and no polyurethane was observed at the margins of the ring.The catheter was deflecting correctly.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that white particle is primarily composed of a polyethylene based material with barium sulfate.This material composite is widely used as radio pacifier along medical device industries.However, source of origin remains unknown.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint cannot be confirmed.The root cause of the damage and foreign material on electrode 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.Manufacture reference no: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9595637
• MDR Text Key: 178238555
• Report Number: 2029046-2020-00102
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• 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: 12/02/2019

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: 06/10/2020
• Device Catalogue Number: D133605IL
• Device Lot Number: 30236132M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 01/15/2020; 02/24/2020
• Supplement Dates FDA Received: 02/11/2020; 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1