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Model Number M00558410 |
Device Problems
Unsealed Device Packaging (1444); Packaging Problem (3007)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 for an esophageal/pyloric wireguided balloon dilatation procedure performed on (b)(6) 2019.According to the complainant, it was noted that the sterile device pouch was already unsealed and open when unpacked.Additionally, the pouch was completely empty.The procedure was completed with another cre wireguided dilatation balloon.There have been no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Block h6: problem code 1444 captures the reportable event of packaging seal compromised.Block h10: investigation results a visual examination of the returned complaint device confirmed that the pouch was empty when received.It was also noted that the package bonds around the pouch were open in the top and bottom seals.The fact the pouch has returned opened indicates that the device was manipulated.Hence, it is possible that the pouch was opened and manipulated by the customer during the preparation prior to being used, contributing to the reported event.However, there is not enough information, objective evidence, or descriptive conditions to understand what could have caused the reported event.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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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 for an esophageal/pyloric wireguided balloon dilatation procedure performed on (b)(6) 2019.According to the complainant, it was noted that the sterile device pouch was already unsealed and open when unpacked.Additionally, the pouch was completely empty.The procedure was completed with another cre wireguided dilatation balloon.There have been no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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