Model Number M001145520 |
Device Problem
Break (1069)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/22/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Complainant name: (b)(6) medical ctr.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
|
|
Event Description
|
It was reported that shaft break occurred.The target lesion was located in the left femoral vein.A 16-4/5.8/75 xxl¿ esophageal balloon catheter was advanced for dilatation.However, the balloon broke off inside the sheath.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
|
|
Manufacturer Narrative
|
Device evaluated by mfr.: the complaint device was received for analysis.The balloon bond, balloon and tip of the device were completely detached from the shaft of the device.The shaft was not returned for analysis.The balloon and balloon bond was completely detached from the shaft at the site of the balloon bond.Blood was visible on the outside of the balloon.Due to the condition of the returned device it was not possible to inflate the balloon.A visual and microscopic examination of the balloon and balloon bond could not find any damage or tear¿s within the balloon material.No issues were noted with the balloon or balloon bond which could have contributed to the complaint incident.A visual and microscopic examination identified no damage or issues with the tip or markerbands of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the device is an esophageal balloon but it was used in the iliac vein and the dfu states: ''the xxl balloon dilatation catheter is intended for use in adult and adolescent populations to dilate strictures of the esophagus.'' (b)(4).
|
|
Event Description
|
It was reported that shaft break occurred.The target lesion was located in the left femoral vein.A 16-4/5.8/75 xxl¿ esophageal balloon catheter was advanced for dilatation.However, the balloon broke off inside the sheath.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
|
|
Search Alerts/Recalls
|