Age at time of event: 18 years or older.
Device evaluated by mfr.
: it is indicated that the device will not be returned for evaluation.
A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.
If there is any further relevant information from that review, a supplemental medwatch will be filed.
(b)(4).
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It was reported that balloon pinhole occurred.
Vascular access was obtained via the femoral artery.
The 16mm in diameter target lesion was located in a non-tortuous and non-calcified vein.
A 16-4/5.
8/120 xxl¿ esophageal balloon catheter was advanced for dilatation.
However, during the first inflation at 4 atmospheres for 60 seconds, the balloon was noted to be leaking and did not fully inflate.
The balloon was then deflated and blood was found in the inflation device.
The physician felt there were some holes in the balloon.
No patient complications were reported and the patient's status was stable.
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