MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY LUMBAR CATHETER KIT, OPEN TIP, 84 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 44406

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problems Dizziness (2194); Device Embedded In Tissue or Plaque (3165)

Event Date 02/19/2017

Event Type  Injury  

Manufacturer Narrative

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or tears.¿ the ifu also cautions that ¿to avoid possible transection of the catheter, the catheter should never be withdrawn through the tuohy needle.If the catheter needs to be withdrawn, the tuohy needle and catheter (with guidewire, if used) must be removed simultaneously.¿ a review of the manufacturing records was not possible as no lot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.

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: LUMBAR CATHETER KIT, OPEN TIP, 84 CM
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 6543021
• MDR Text Key: 74355556
• Report Number: 2021898-2017-00255
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 44406
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention