Catalog Number 50318 |
Device Problem
Break (1069)
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Patient Problem
No Code Available (3191)
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Event Date 03/17/2017 |
Event Type
Injury
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Manufacturer Narrative
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The product testing is in progress.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported to medtronic neurosurgery that a physician stated the catheter broke off during a procedure during insertion.According to the report, the catheter popped off/snapped while in the patient during the procedure.Reportedly, the patient experienced pneumocephalus.Per the surgeon, the current status of the patient was fine and they had returned to baseline.
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Manufacturer Narrative
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Additional information received reported that due to the catheter breaking, the surgeon was delayed in relieving the intracranial pressure of the brain and the patient developed pneumocephalus.According to the report, a different manufacturer¿s catheter was used.It was noted that some breakage happened after the catheter had been sutured in the ventricles of the patient¿s brain.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information received reported that no unintended section of the catheter remained inside of the patient's body and no additional procedures were required due to the reported event.This reported event is 1 of 3 similar events.Please refer to manufacturer reports #2021898-2017-00223 and #2021898-2017-00224 for details regarding the other two events.The catheter was returned in two pieces of lengths 20 cm and 12 cm respectively.Both edges at tear site appeared to be jagged.It is unknown how or when the damage occurred.The returned segments were patent and passed leak testing when tested individually.Proteinaceous debris was observed within the interior and exterior of the catheter.A review of the manufacturing records for the supplied catheter showed no anomalies.All supplied catheters are 100% inspected at the time of manufacture.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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