MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM LUMBAR DRAINAGE KIT; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Catalog Number	27302
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned lumbar catheter was patent and met the requirements for leak testing.Proteinaceous debris observed on the exterior of the catheter.The distal end of the catheter appears to be jagged.It is unknown how or when the damage occurred.The catheter also met all of the requirements for the tensile strength and ultimate elongation tests.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or tears.¿ the ifu also cautions that ¿to avoid possible transection of the catheter, the catheter should never be withdrawn through the tuohy needle.If the catheter needs to be withdrawn, the tuohy needle and catheter (with guidewire, if used) must be removed simultaneously.¿ a review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that upon insertion of the catheter, it was decided to pull the catheter out as it was not in a good space without the tuohy needle in position.According to the report, the catheter snapped off and was left in the patient.Reportedly, the physician decided to leave it there and indicated it would be fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDM LUMBAR DRAINAGE KIT
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6411434
• Report Number: 2021898-2017-00113
• Device Sequence Number: 13684234
• Product Code: GWM
• UDI-Device Identifier: 00673978246031
• UDI-Public: 00673978246031
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K802100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 27302
• Device Lot Number: 212141015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 91