Model Number N/A |
Device Problems
Calcified (1077); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.
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Event Description
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Information was provided that during a biliary drainage catheter exchange procedure, the stent was calcified in.The sales rep further stated that "he did not unlock the stent.That was the issue." additional information was requested, but as the report date ((b)(6) 2016), no further information has been provided.
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Manufacturer Narrative
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Product has not been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.
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Event Description
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Information was provided that during a biliary drainage catheter exchange procedure, the stent was calcified in.The sales rep further stated that "he did not unlock the stent.That was the issue." additional information was requested, but as the report date ((b)(6) 2016), no further information has been provided.
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Manufacturer Narrative
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Investigation - evaluation: a review of the documentation, instructions for use (ifu), trends and quality control was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Based on the information provided, no product returned and the results of our investigation, user error caused or contributed to the event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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Event Description
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Information was provided that during a biliary drainage catheter exchange procedure, the stent was calcified in.The sales rep further stated that "he did not unlock the stent.That was the issue." additional information was requested, but as of the report date (08 sept 2016), no further information has been provided.Additional information received: the nurse stated that "i do not think you need to research this.The surgeon did not know how to work the device.".
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Search Alerts/Recalls
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