BIOSENSE WEBSTER INC CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL; INTRODUCER, CATHETER
|
Back to Search Results |
|
Model Number D138501 |
Device Problem
Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
|
|
Event Description
|
It was reported that a patient underwent cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small where a hemostatic valve separation issue occurred.It was reported that the hemostatic valve on the carto vizigo¿ 8.5f bi-directional guiding sheath - small was weak and the although the number of times the catheter was taken in and out was small, the physician thought there was problem with this product.The physician commented that the device is good to use, but there is no trouble with agilis, and using carto vizigo¿ 8.5f bi-directional guiding sheath - small may reduce the treatment success rate.There was no procedure delay.The procedure was completed without patient's consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The event was assessed as a mdr reportable hemostatic valve separation issue.
|
|
Manufacturer Narrative
|
Additional information was received on 12/20/2020 stating that this complaint is a follow-up (duplicate) to manufacturer¿s reference number (b)(4)/manufacturer report number 2029046-2020-01960.Therefore, any additional updates received will continue to be reported under manufacturer¿s reference number (b)(4)/manufacturer report number 2029046-2020-01960).Manufacturer's reference number: (b)(4).
|
|
Search Alerts/Recalls
|
|
|