MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number F5QA252RT

Device Problems Break (1069); Material Twisted/Bent (2981); Patient Device Interaction Problem (4001)

Patient Problem Perforation of Vessels (2135)

Event Date 07/14/2021

Event Type  Injury  

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 (b)(6) male patient underwent an electrophysiological examination procedure with a webster catheter.The catheter tip broke and became knotted and ultimately had to be surgically removed.The webster catheter was inserted into the vena femoralis for a diagnostic electrophysiology procedure.During the procedure, the catheter tip broke after having vascular wall contact.The broken position was visible under fluoroscopy.The physician tried to retrieve the catheter, but due to the broken tip it was not possible to remove the catheter from the vein.Twisting and pulling the catheter resulted in becoming knotted and ultimately having to be surgically removed.The vena femoralis had to be opened completely in the area of the groin., this adverse event was discovered during use of biosense webster, inc.(bwi) products.The physician¿s opinion on the cause of this adverse event was a bwi product malfunction.The patient required extended hospitalization because of the necessary additional surgical intervention to remove the catheter from the vein.Healing time and length of stay in hospital was extended.A thermocool® smarttouch® sf catheter was not used.No ablation was performed.The broken tip and the knotted catheter issues were assessed as mdr reportable malfunctions.Since the event is life threatening and required intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 17-aug-2021.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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

It was reported that a 44-year-old male patient underwent an electrophysiological examination procedure with a webster catheter.The webster catheter was inserted into the vena femoralis for a diagnostic electrophysiology procedure.During the procedure, the catheter tip broke after having vascular wall contact.The broken position was visible under fluoroscopy.The physician tried to retrieve the catheter, but due to the broken tip it was not possible to remove the catheter from the vein.Twisting and pulling the catheter resulted in becoming knotted and ultimately having to be surgically removed.The vena femoralis had to be opened completely in the area of the groin.The patient required extended hospitalization because of the necessary additional surgical intervention to remove the catheter from the vein.Healing time and length of stay in hospital was extended.No ablation was performed.The device evaluation was completed on 27-oct-2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the tip was separated from the shaft.Outer diameter (od) test was performed and device was found within specifications.The sample was sent to scanning electron microscope (sem) analysis for further investigation and results showed evidence of mechanical damage and that it was elongated until it became separated.Also, no cut marks were found.Thus, this is related to excessive force and probably due to the patient anatomy but this could not be conclusively determined.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.Complaint regarding the broken tip was confirmed; however, it cannot be confirmed if the device contributed to the knotted condition and adverse event since od¿s were found within specifications and as per sem analysis, there was evidence of mechanical damage.The adverse event remains unknown.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿adverse event¿ and ¿knotted catheter¿ issues.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the customer¿s reported ¿broken tip¿ issue.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: WEBSTER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12320939
• MDR Text Key: 266677552
• Report Number: 2029046-2021-01339
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10846835007213
• UDI-Public: 10846835007213
• Combination Product (y/n): N
• PMA/PMN Number: K892265
• 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: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2024
• Device Model Number: F5QA252RT
• Device Catalogue Number: F5QA252RT
• Device Lot Number: 30538443M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR KIT-WW
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR