MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED, 90 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	43103
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Headache (1880)
Date of Event	01/30/2019
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
It was reported that the catheter ruptured at the third thoracic vertebrae, affecting cerebrospinal fluid drainage.As a result the patient experienced increased intracranial pressure and headaches.The fracture was "flush" and the patient's skin did not show any trauma.It was stated there was no traumatic incision on the surface of the skin.The issue was presumed to be due to a pipeline quality problem.The patient's condition was temporarily stable, but the intracranial pressure was high.It was planned to have a second operation for the patient on (b)(6) 2019 where the old catheter and valve would be removed and replaced with new product of the same model.
Additional Manufacturer Narrative
The returned catheter was returned in two segments.There is damage to one end of each segment.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¿ due to the catheter breakage, the catheter did not meet the requirements for leak and patency testing.Water was able to flow through the two segments of the catheter without obstruction.The catheter met the requirements of tensile testing.Therefore, the nature of the complaint could not be replicated by the laboratory technician.Most of the graphite was removed from the slits of the catheter.No anomalies were found during a review of the design history record.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: CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED, 90 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8348204
• Report Number: 2021898-2019-00060
• Device Sequence Number: 1994866
• Product Code: JXG
• UDI-Device Identifier: 00643169466821
• UDI-Public: 00643169466821
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K792005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: 06/30/2022
• Device Model Number: 43103
• Device Catalogue Number: 43103
• Device Lot Number: E33747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 05/09/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 30 YR