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

Model Number	27303
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient was implanted with a lumbosacral drainage device on (b)(6) 2019, and during the operation, the catheter broke after opening the package.The hospital unpacked a stock product for replacement.
Additional Manufacturer Narrative
The returned product was returned in two segments being 6.5 and 26.5 inches in length.A luer lock connector was attached to the 6.5 inch segment.The catheter could not be tested for leak and patency testing due to the breakage.Water was able to flow through both segments without obstruction.Most of the catheter met the requirements for tensile testing.There were several kinks in the catheter and appeared to be overstretched at the location of the break.This area of the catheter did not meet the requirements for tensile testing.It is unknown how or when this damage occurred.The instructions for use cautions, ¿improper use of instruments in handling or implanting edm catheter products may result in the cutting, slitting, breakage or crushing of components.¿ there was proteinaceous debris observed on the device.The instructions for use cautions, ¿poor recording of icp will result if the catheter, patient line or other components of the monitoring system become clogged with blood clots, brain tissue fragments or fibrous debris.¿ all catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KIT
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8518402
• Report Number: 2021898-2019-00149
• Device Sequence Number: 13828316
• Product Code: GWM
• UDI-Device Identifier: 00673978246048
• UDI-Public: 00673978246048
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K802100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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: 09/30/2022
• Device Model Number: 27303
• Device Catalogue Number: 27303
• Device Lot Number: 214264871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 06/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1