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

Catalog Number D133604IL

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2019

Event Type  malfunction  

Manufacturer Narrative

The investigational analysis completed 11/14/2019.The device was inspected and the shaft was observed slightly lifted near distal tip with bent pins.During the second visual, the shaft was observed lifted-bar exposed, and pins were noticed bent in the connector.The catheter was tested for deflection and the catheter failed.The catheter was analyzed in and it was noticed that the t bar slid down from its place.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint was confirmed.The root cause of peek housing transition cracked is related to the t-bar that slid down.The root cause of the connector pin damage 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 root cause of t-bar slid down and cannot be determined.However, it will further investigated under an internal investigation.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial tachycardia (at) with a thermocool® smart touch¿ electrophysiology catheter, and the biosense webster inc.(bwi) product analysis lab (pal) observed the shaft lifted.Initially, it was reported that during at procedure, the catheter could not deflect to specification.A second catheter was then used to complete the procedure.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 10/24/2019, the bwi pal received the device for evaluation.Upon initial inspection, the shaft was observed slightly lifted near the distal tip, with bent pins.Further testing was then performed.On 10/31/2019, a second visual inspection confirmed the initial findings of a lifted shaft near the distal tip.In addition, the t bar was exposed.The observed lifted shaft has been assessed as an mdr reportable malfunction as the the device integrity was not maintained.The awareness date was rest to 10/24/2019.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9344861
• MDR Text Key: 195388252
• Report Number: 2029046-2019-03901
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2019

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: 03/10/2020
• Device Catalogue Number: D133604IL
• Device Lot Number: 30188191M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1