BOSTON SCIENTIFIC - COSTA RICA (COYOL) DREAMTOME¿ RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00584040 |
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 11/24/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Reported event of guidewire distal tip detached exposing the tip of the metal corewire.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a dreamtome¿ rx 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the stent was loaded onto the dreamwire guidewire that was already in place, as they were deploying the stent, the physician experienced difficulty removing the dreamwire guidewire from the delivery catheter.When the physician pulled the guidewire back, it was noticed that the hydrophilic coating got detached inside the patient, exposing the tip of the metal corewire.The guidewire and delivery catheter for the stent were removed and the detached portion of the hydrophilic coating of the guidewire was successfully retrieved using a captiflex snare.The procedure was completed using this device.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 fine.
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Manufacturer Narrative
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Visual analysis of the tome device has the working length twisted.The guidewire returned has the jacket peeled exposing the corewire in the middle section.The core wire was intact and the distal tip (polymer tip) was detached exposing the corewire end.The complaint is consistent with the returned guidewire since the distal tip got detached, exposing the corewire tip.It is most likely that the failures found could have been generated during the procedure due to clinical or procedure factors.Therefore, the most probable root cause is "operational context¿, since it is most likely that due to anatomical and/or procedural factors encountered during the procedure, performance was limited.A dhr (device history record) review was performed and no deviation was found.
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Event Description
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It was reported to boston scientific corporation that a dreamtome¿ rx 44 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the stent was loaded onto the dreamwire guidewire that was already in place, as they were deploying the stent, the physician experienced difficulty removing the dreamwire guidewire from the delivery catheter.When the physician pulled the guidewire back, it was noticed that the hydrophilic coating got detached inside the patient, exposing the tip of the metal corewire.The guidewire and delivery catheter for the stent were removed and the detached portion of the hydrophilic coating of the guidewire was successfully retrieved using a captiflex snare.The procedure was completed using this device.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 fine.
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Search Alerts/Recalls
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