MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICULAR CATHETER, STANDARD, BARIUM IMPREGNATED, 23 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	41101
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the catheter was embrittled and cracked when the surgeon placed it.As a result the device was replaced with another catheter.It was noted that the surgeon was trying to place the catheter into the ventricular for csf drainage.No broken pieces remained inside the patient.There was no delay in surgery.
Additional Manufacturer Narrative
The ventricular catheter was returned in three separate pieces.Due to this, the catheter could not be tested for patency and leakage.The longest segment was used to perform a tensile test.This segment met the requirements for tensile strength and ultimate elongation.Due to the short length of the returned catheter segments, only the longest segment could be tested.Therefore, the standard deviation of the tensile strength and ultimate elongation could not be calculated.There was damage to one of the ends of the catheter with a length of 5.35 inches and 2.4 inches.The catheter with a length of 1.65 inches had damage to both ends.It is unknown how this damage occurred.The instructions for use cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components.Such damage may lead to loss of shunt integrity, and necessitate premature surgical revision of the shunt system.¿ all catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the catheter was embrittled and cracked when the surgeon placed it.As a result the device was replaced with another catheter.It was noted that the surgeon was trying to place the catheter into the ventricular for csf drainage.No broken pieces remained inside the patient.There was no delay in surgery.

• Brand Name: VENTRICULAR CATHETER, STANDARD, BARIUM IMPREGNATED, 23 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8430113
• Report Number: 2021898-2019-00112
• Device Sequence Number: 16191129
• Product Code: JXG
• UDI-Device Identifier: 00643169466500
• UDI-Public: 00643169466500
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K792007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 41101
• Device Catalogue Number: 41101
• Device Lot Number: E37037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention