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 Date 05/19/2017 |
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 as it is implanted in the patient; 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 kit was used during a percutaneous endoscopic gastrostomy procedure.The procedure date is unknown.According to the complainant, on (b)(6) 2017, the home health nurse reported that the peg tube would not flush because it was occluded.Reportedly, the patient¿s tube has not been flushed since (b)(6)2017.Patient states he doesn¿t know how to flush the tube or how to connect pump.Proceduralist and nurse to follow up with patient.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 kit was used during a percutaneous endoscopic gastrostomy procedure.The procedure date is unknown.According to the complainant, on (b)(6) 2017, the home health nurse reported that the peg tube would not flush because it was occluded.Reportedly, the patient¿s tube has not been flushed since (b)(6) 2017.Patient states he doesn¿t know how to flush the tube or how to connect pump.Proceduralist and nurse to follow up with patient.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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