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

Model Number D134805

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The biosense webster, inc.Product analysis lab received the device for evaluation.Device evaluation summary: upon receipt, the catheter was visually inspected and it was found shaft was damaged near the shaft-tip transition.The force test was unable to be performed due to the damaged shaft.During the manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage from leaving the facility.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint regarding the vector frozen cannot be duplicated during the product investigation.However, the damaged shaft could be related to the reported issue.The root cause of the damaged shaft 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 but this cannot be conclusively 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

It was reported that a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed the shaft damaged near the shaft tip transition.Initially it was reported that during pulmonary vein isolation (pvi), the vector freezed.The thermocool® smart touch® sf bi-directional navigation catheter was reconnected but the issue continued.The issue was resolved by changing the catheter.The procedure was completed without patient's consequence.The biosense webster, inc.Product analysis lab received the device for evaluation and observed on june 26, 2020 that the shaft was damaged near the shaft tip transition.Since there was no mention of any damage to the integrity of the device in the event description, it is most probable that the damage was inflicted during post-procedural handling and shipment.Some hospitals practice cutting the tip of the catheter to prevent re-use.Per the response received, the timing of the damage could not be confirmed.Therefore, this returned condition was conservatively assessed as a mdr reportable issue.The awareness date for this issue is june 26, 2020.

• 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
• 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: 10317127
• MDR Text Key: 200456290
• Report Number: 2029046-2020-00926
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30335451M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Date Manufacturer Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1