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

Catalog Number D133604IL

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Requesting clarification on the initial reporter facility name.If additional information is received a supplemental 3500a report will be submitted to the fda.Device evaluation summary: visual analysis was performed and the distal tip was bent at the pebax and there kinks in shaft next to shrink sleeving.A second closer inspection was performed and it was observed that electrode# 4 was without pu in the proximal section, spring helix and pebax sleeve bent and kinks in shaft next to shrink sleeving.No other damages or internal parts exposed were observed.Magnetic sensor functionality was tested on carto and the catheter failed, error 106 was observed.A failure analysis was performed, and the catheter was dissected on the tip area, loss of electrical continuity at the sensor was found.It was determined that the root cause was an internal failure of the sensor.Additionally, a tilt test was performed and the catheter failed.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The root cause of the damage on the electrode, peek housing and spring helix, pebax sleeve bent and kink in shaft cannot be related to the manufacturing process since there was 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 shipment; however, this cannot be conclusively determined.The root cause of the internal failure of the sensor cannot be determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

On may 27, 2020, this thermocool® smart touch¿ electrophysiology catheter was received by the biosense webster failure analysis lab as a wrong device product under manufacturer reference number (b)(4).Manufacturer reference number (b)(4) was assessed as not reportable for a magnetic sensor error issue.An investigation was performed to determine if there was an existing manufacturer reference number for this wrong device received.However, no additional information was provided.Therefore, since we were unable to determine if there is an existing manufacturer reference number, we have made the decision to create a related manufacturer reference number under (b)(4).The first visual finding from the biosense webster failure analysis lab for this wrong device received was received on june 11, 2020 that the distal tip was bent at the pebax and there were kinks in the shaft next to the shrink sleeving.The observed bent and the kinks were assessed as not mdr reportable.If there¿s a slight bent in the shaft; however, no internal components are exposed, then the potential that it could cause or contribute to a death or serious injury was remote.After further review on june 15, 2020, a kink was observed on the peek housing and the electrode# 4 without polyurethane (pu) on the proximal section.The spring helix and pebax sleeve were bent and there were kinks in the shaft next to the shrink sleeving.No other damages or internal parts exposed were observed.The observed condition of the electrode #4 without pu on the proximal section was assessed as a reportable mdr issue.Therefore, the awareness date for this reportable lab finding is june 15, 2020.

Manufacturer Narrative

Additional information was received on (b)(6) 2020 providing the facility name and phone number.Therefore, have completed fields e1.Initial reporter facility name and e1.Initial reporter address line 1.E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 10268811
• MDR Text Key: 202103886
• Report Number: 2029046-2020-00859
• 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
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2020
• Device Catalogue Number: D133604IL
• Device Lot Number: 30244102M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1