Model Number M0055658010 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/30/2014 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2014.According to the complainant, during the procedure, while inserting the jagwire guidewire into the sphincterotome, the hydrophilic tip was detached inside the patient exposing the tip of the metal corewire.The detached tip was not retrieved.The procedure was completed with a new jagwire guidewire.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Reported event of guidewire distal tip detached exposing the tip of the metal corewire.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2014.According to the complainant, during the procedure, while inserting the jagwire guidewire into the sphincterotome, the hydrophilic tip was detached inside the patient exposing the tip of the metal corewire.The detached tip was not retrieved.The procedure was completed with a new jagwire guidewire.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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A visual examination of the guidewire revealed that the distal tip was detached exposing the tip of the metal corewire approximately 1.5cm.Presence of adhesive remnants were found indicating that the pebax was properly attached to the corewire.No evidence of corewire fractured.The complaint is consistent with the return that the distal tip was detached exposing the tip of the metal corewire.Based on all gathered information, the most probable root cause is undeterminable.A dhr (device history record) review was performed and no deviation was found.
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Search Alerts/Recalls
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