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

Catalog Number D133604IL

Device Problems Break (1069); Sharp Edges (4013)

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

Event Date 04/18/2021

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool¿ smart touch" electrophysiology catheter and a broken tip issue occurred.There was physical damage reported.The physician opened the package and found the tip of the catheter was lack of one small part.The metal/electric wire was not explored.Therefore, the physician did not use it in patient and switched another new one to complete the procedure.There was no patient consequence reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information available, this event was assessed as a mdr reportable broken tip issue.

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30508956m number, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Initially it was reported that there was physical damage.The physician opened the package and found the tip of the catheter was lack of one small part.The metal/electric wire was not explored.Multiple attempts had been made to obtain clarification to this complaint.However, no further information has been made available.Therefore, with the information available, the event was assessed as a mdr reportable broken tip issue.The biosense webster, inc.Product analysis lab received the device for evaluation on (b)(6)-2021 and per the evaluation completion on (b)(6)-2021 observed a different additional finding as electrode 2 was damaged as the electrode was bent and lifted.The described electrode damaged was also assessed as mdr reportable.The awareness date for this reportable lab finding is (b)(6)-2021.Therefore, added h6.Medical device problem code of "sharp edges (a051102).The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and review the eeprom of the returned device.Visual analysis of the returned sample revealed that electrode 2 was damaged, the electrode was bent and lifted.The eeprom was read and it was noticed that the first use was on (b)(6)2021, the alert date of the complaint event.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device 30508956m number, and no internal action related to the complaint was found during the review.This unit was inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) of this device per its part number that indicates proper manufacturing in accordance with documented specifications and procedures.At this time is not possible to determine the root cause of this condition, however, based on the information provided, the condition reported has origin in someplace external to the manufacturing environment.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: 11830442
• MDR Text Key: 266202712
• Report Number: 2029046-2021-00763
• 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: 10/07/2021

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: 02/10/2022
• Device Catalogue Number: D133604IL
• Device Lot Number: 30508956M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2021
• Initial Date Manufacturer Received: 04/18/2021
• Initial Date FDA Received: 05/16/2021
• Supplement Dates Manufacturer Received: 06/04/2021; 09/11/2021
• Supplement Dates FDA Received: 06/04/2021; 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER