BOSTON SCIENTIFIC - MARLBOROUGH ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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Model Number UNK518 |
Device Problem
Occlusion Within Device (1423)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that an endovive initial placement peg kit was used during a percutaneous endoscopic gastrostomy procedure.The procedure date is unknown.According to the complainant, the patient's wife called stating that the patient's pump was alarming last night (exact date is unknown) and stated "high pressure".They tried using the spare pump but still it stated ¿high pressure.¿ the wife also stated that there were no kinks noted on the tube and there were no any other visible issues with the tube.She tried to flush the peg tube using cooled boiled water but it would not flush because it was occluded.The wife was advised to flush the tube using soda water and to call back if would not work so that a duodopa nurse specialist visit can be arranged.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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Event Description
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It was reported to boston scientific corporation that an endovive initial placement peg kit was used during a percutaneous endoscopic gastrostomy procedure.The procedure date is unknown.According to the complainant, the patient's wife called stating that the patient's pump was alarming last night (exact date is unknown) and stated "high pressure".They tried using the spare pump but still it stated ¿high pressure.¿ the wife also stated that there were no kinks noted on the tube and there were no any other visible issues with the tube.She tried to flush the peg tube using cooled boiled water but it would not flush because it was occluded.The wife was advised to flush the tube using soda water and to call back if would not work so that a duodopa nurse specialist visit can be arranged.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on september 5, 2017.It was confirmed that the reported tubing is not manufactured by boston scientific.
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