MEDTRONIC NEUROSURGERY LUMBAR CATHETER KIT, OPEN TIP, 84 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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Catalog Number 44406 |
Device Problems
Break (1069); Device Or Device Fragments Location Unknown (2590)
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Patient Problems
Dizziness (2194); Device Embedded In Tissue or Plaque (3165)
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Event Date 02/19/2017 |
Event Type
Injury
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Manufacturer Narrative
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Approximately 24 cm of the returned lumbar catheter was patent and met the requirements for leak testing.Proteinaceous debris observed on the exterior of the catheter.The proximal end of the catheter appears to be jagged.It is unknown how or when the damage occurred.The instructions for use (ifu) that accompany the device caution that ¿low tear strength is a characteristic of most unreinforced silicone elastomer materials.Care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks or tears.¿ the ifu also cautions that ¿to avoid possible transection of the catheter, the catheter should never be withdrawn through the tuohy needle.If the catheter needs to be withdrawn, the tuohy needle and catheter (with guidewire, if used) must be removed simultaneously.¿ a review of the manufacturing records was not possible as no lot number was provided.All catheters are 100% inspected at the time of manufacture.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 at the end of (b)(6), a lp shunt surgery was conducted, and the patient was discharged with a good condition in early (b)(6).According to the report, on (b)(6) 2017, the patient complained of dizziness.They were admitted again and fluoroscopic imaging revealed that the lumbar catheter was fractured.It was stated that part of the catheter was fully interfered in the vertebral canal on the spinal cord and could not be extracted.Reportedly, on (b)(6) 2017, a revision surgery was performed, and the lp shunt was changed to the vp shunt, and the patient's condition was stable.
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Manufacturer Narrative
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Approximately 24 cm of the returned lumbar catheter was patent and met the requirements for leak testing.Proteinaceous debris observed on the exterior of the catheter.The proximal end of the catheter appears to be jagged.It is unknown how or when the damage occurred.The instructions for use (ifu) that accompany the device caution that ¿low tear strength is a characteristic of most unreinforced silicone elastomer materials.Care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks or tears.¿ the ifu also cautions that ¿to avoid possible transection of the catheter, the catheter should never be withdrawn through the tuohy needle.If the catheter needs to be withdrawn, the tuohy needle and catheter (with guidewire, if used) must be removed simultaneously.¿ a review of the manufacturing records was not possible as no lot number was provided.All catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
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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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