MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM VENTRICULAR CATHETER, LARGE DIAMETER, 35 CM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	27703
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2018
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 that when the external drainage tube was placed in the ventricle puncture, a crack was found in the catheter at 13cm.The catheter was replaced and a new one was used for the patient for extraventricular drainage.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
Analysis found that 35 cm of the edm ventricular catheter was returned.Proteinaceous debris was observed within the interior and exterior of the catheter.Between the 13 and 14 mark on the catheter cuts were observed.The catheter did not meet the requirements of the leak test due to the cuts observed.It is not known how, or when this damage occurred.The ifu cautions in the ¿warnings and precautions¿ section that, ¿improper use of instruments in handling or implanting edm catheter products may result in the cutting, slitting, breakage or crushing of components.¿ no other unusual characteristics were noted.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
Additional information received reported that no external/environmental factors that may have led to the issue were identified.

• Brand Name: EDM VENTRICULAR CATHETER, LARGE DIAMETER, 35 CM
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8016795
• Report Number: 2021898-2018-00522
• Device Sequence Number: 1578404
• Product Code: GWM
• UDI-Device Identifier: 00643169496880
• UDI-Public: 00643169496880
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K984053
• 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): 11/30/2018

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: 27703
• Device Catalogue Number: 27703
• Device Lot Number: E39614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 12/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR