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Model Number M00558480 |
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 04/19/2018 |
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.
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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) 2018.According to the complainant, during unpacking, a hole was noted on the packaging of the device.Reportedly, this was not used in a patient or procedure.
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Manufacturer Narrative
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A visual examination of the complaint device revealed that the pouch had indentations marks on the front right lower side of the pouch.The packaging was not perforated; none of the indentations compromised the sterility of the device.The sealed sides of the pouch were inspected and noted to be in good condition with no damages.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 an (b)(6) 2018.According to the complainant, during unpacking, a hole was noted on the packaging of the device.Reportedly, this was not used in a patient or procedure.
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Search Alerts/Recalls
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