BOSTON SCIENTIFIC - COSTA RICA (COYOL) PERCUFLEX¿ URINARY DIVERSION STENT; CATHETER, NEPHROSTOMY
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Model Number M0061603250 |
Device Problem
Device Packaging Compromised (2916)
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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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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 percuflex¿ urinary diversion stent was supposed to be used for a procedure (exact date not reported).According to the complainant, during unpacking "it was found that the device was not sealed in a sterile bag¿.Reportedly, the device was not received in a sterile device pouch.The device was not used in the procedure, and the procedure was completed with another percuflex¿ urinary diversion stent.There were no patient complications reported as a result of this event.Attempts to obtain details regarding the event description have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.
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Manufacturer Narrative
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A visual inspection of the returned device revealed that the catheter with adaptor was returned without its packaging, and the device has no visible defects.During manufacturing processes the product is 100% inspected for device functionality and integrity to ensure that all finished devices meet specification, however, there is no control of how the unit was handled in the field.There are processes in place in order to verify that the product was properly assembled, and that it was not possible to generate this type of failure during the manufacturing process.Therefore, a definitive root cause could not be determined.The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
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Event Description
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It was reported to boston scientific corporation that a percuflex¿ urinary diversion stent was supposed to be used for a procedure (exact date not reported).According to the complainant, during unpacking "it was found that the device was not sealed in a sterile bag¿.Reportedly, the device was not received in a sterile device pouch.The device was not used in the procedure, and the procedure was completed with another percuflex¿ urinary diversion stent.There were no patient complications reported as a result of this event.Attempts to obtain details regarding the event description have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.
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