Model Number M00558620 |
Device Problems
Unsealed Device Packaging (1444); Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2023 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a cre pro wire guided dilatation balloon was unpackaged for use in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation outside the patient, it was found that the product package was damaged and it was unknown if sterilization was compromised.The device was not used and the procedure was completed with another cre pro wireguided dilatation balloon.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 stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Manufacturer Narrative
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This event was reported by the sales representative.The reported healthcare facility and physician is: (b)(6).Imdrf device code a0205 captures the reportable event of packaging damage.
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Manufacturer Narrative
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Block h6: imdrf device code a020503 is being used to capture the reportable event of packaging seal compromised.
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Event Description
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It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was unpackaged for use in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation outside the patient, it was found that the product package was damaged and it was unknown if sterilization was compromised.The device was not used and the procedure was completed with another cre pro wireguided dilatation balloon.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 stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Correction: no further information has been obtained despite good faith efforts.
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Search Alerts/Recalls
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