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

Model Number D134801

Device Problems Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The device evaluation was completed on 4/29/2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and catheter outer diameter evaluation of the returned device.Visual analysis of the returned sample revealed that foreign material under electrode on the smart touch bidirectional sf catheter.The catheter outer diameter was measured and it was found within specification.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use contain the following recommendations: do not use excessive force to advance or withdraw the catheter when resistance is encountered during catheter manipulation through the sheath.Overall, infrared results revealed that the foreign white particle was primarily composed of a polyethylene -based material with a second component, barium sulfate.This composite material is widely used as radio pacifier along medical device industries.However, source of origin remains unknown.The root cause of foreign material under the electrode observed during analysis cannot be related to the manufacturing process since there is evidence that the device was manufactured correctly.This damage could be related to the handling of the device, procedural factors may contribute.However, 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 an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a the biosense webster, inc.Product analysis lab observed foreign material under an electrode.Initially it was reported when the thermocool® smart touch® sf bi-directional navigation catheter was inserted into the abbott swartz g407371 8.5fr sheath, the physician felt resistance and strongly pushed it in, the part exposed from the sheath broke and it became impossible to operate.The catheter was changed and the procedure was continued.No patient consequence was reported.Additional information received indicated that the damage did not result in wires being exposed.The damage did not result in any lifted or sharp rings.There was no occlusion while irrigating the sheath.The sheath was not narrowed, partially blocked or completely blocked.The catheter was not pre-shaped.The resistance with the sheath was assessed as not mdr reportable.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury was remote.The issue of ¿part exposed from the sheath broke and it became impossible to operate¿ was assessed as a not mdr reportable ¿device issue unspecified¿ issue as multiple attempts had been made to obtain clarification to this complaint.However, no further information had been made available.No patient risk could be identified for this issue.There was no patient consequence or intervention resulting from this device problem.The issue cannot be assessed for patient safety because it was unknown.The biosense webster, inc.Product analysis lab received the device for evaluation and observed on 4/20/2021 foreign material under electrode #2.The foreign material observed during the bwi lab evaluation was assessed as a mdr reportable issue.The awareness date for this reportable lab finding is 4/20/2021.

• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11815390
• MDR Text Key: 266681618
• Report Number: 2029046-2021-00736
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30448170M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2020
• 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