Model Number M00556581 |
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 12/08/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been received for analysis.Upon 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) 2015.According to the complainant, during the procedure, the physician found that the device could not be inserted into the duodenal papilla.The device was retrieved and it was noted that the hydrophilic tip detached, exposing the tip of the metal core wire.Nothing detached inside the patient.The procedure was completed with another 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 evaluation of the returned guidewire revealed that the tip of the guidewire was peeled, exposing the corewire by approximately 0.5cm.The tip of the metal corewire was not exposed.Sanding marks were found on the corewire.Evidence of adhesive remnants were found which indicate that the pebax tip was correctly adhered during the manufacturing process.There was no evidence of corewire fracture.The complaint is not consistent with the returned guidewire since the tip was peeled and the tip of the metal corewire was not exposed.Based on all gathered information, the investigation fails to determine a definite root cause.A dhr (device history record) review was performed and no deviation was found.A labeling review was performed and there is no evidence that the device was not used in accordance with the labeling.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
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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) 2015.According to the complainant, during the procedure, the physician found that the device could not be inserted into the duodenal papilla.The device was retrieved and it was noted that the hydrophilic tip detached, exposing the tip of the metal core wire.Nothing detached inside the patient.The procedure was completed with another 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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Search Alerts/Recalls
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