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Model Number M0062101170 |
Device Problems
Burst Container or Vessel (1074); Difficult to Remove (1528)
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Patient Problems
Hemorrhage/Bleeding (1888); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and 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 nephromax dilatation balloon catheter was used during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon burst.Reportedly, the sheath got stuck in the tissue but was eventually taken out without extra bleeding.The procedure was completed a different device.No patient complications have been reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Event Description
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It was reported to boston scientific corporation that a nephromax dilatation balloon catheter was used during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon burst.Reportedly, the sheath got stuck in the tissue but was eventually taken out without extra bleeding.The procedure was completed a different device.No patient complications have been reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.***additional information received on (b)(6), 2020*** it was reported that the anatomy location was in the kidney.Also, the balloon was noted to burst at under 20 atm.The patient had a minor bleeding as a result of this event; however, the patient was stable at the conclusion of the procedure.
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Manufacturer Narrative
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Block h6: problem code 1074 captures the reportable event of balloon burst.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not been received for analysis.Upon receipt and 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.Additional information: block b5 (describe event or problem) block e1 (physician's first name and initial reporter address 2) block h6 (patient code).
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Search Alerts/Recalls
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