Model Number M00558660 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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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.(b)(4).
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Event Description
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It was reported to boston scientific corporation that a cre wireguided dilatation balloon was unpacked on (b)(6) 2017.According to the complainant, there were pinholes on the device pouch packaging but the outer box was intact.The sterile seal of the packaging was compromised.There was no patient involvement and the defect was noticed prior to a procedure.
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Manufacturer Narrative
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Investigation results: a visual examination of the complaint device revealed the pouch was damaged as there were indentations in the pouch material.The package bonds were inspected around the pouch and found to be continuous and intact.The noted defect likely occurred due to handling of the device or portion of the device without direct patient contact either during shipping, unpacking or preparation of the device for the procedure.Therefore, the most probable root cause of this complaint is handling damage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other 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 cre wireguided dilatation balloon was unpacked on (b)(6) 2017.According to the complainant, there were pinholes on the device pouch packaging but the outer box was intact.The sterile seal of the packaging was compromised.There was no patient involvement and the defect was noticed prior to a procedure.
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Search Alerts/Recalls
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