BIOSENSE WEBSTER INC NAVI-STAR THERMO-COOL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
|
Back to Search Results |
|
Model Number NI75TCBH |
Device Problems
Crack (1135); Positioning Problem (3009)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/22/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The product was returned to biosense webster inc.(bwi) for evaluation on (b)(6) 2021.Bwi conducted a visual inspection and deflection evaluation of the returned device.Visual analysis of the returned sample revealed the peek housing cracked with internal parts exposed on the navistar thermocool catheter.Deflection test was performed on the catheter and it was found within specifications.No malfunction was observed.A manufacturing record evaluation was performed for the finished device 30548331m number, 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 event described could not be confirmed as the as the device performed without any deflection issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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 supraventricular tachycardia (svt) procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and the biosense webster inc, (bwi) product analysis lab found the peek housing cracked with internal parts exposed.Initially, it was reported that during the svt operation, the catheter was unable to deflect or relax completely.A second catheter was used to complete the operation.No adverse patient consequences were reported.The deflection issue was assessed as not mdr reportable.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found on (b)(6) 2021 that the peek housing was cracked with internal parts exposed.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is (b)(6) 2021.
|
|
Search Alerts/Recalls
|
|
|