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

Model Number	27703
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
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 during the operation, when the package was unpacked, a hole was found in the catheter wall between the patient's end 13-14cm.The catheter was replaced.
Additional Manufacturer Narrative
The returned catheter was on the stylet upon arrival.The catheter was 14.5 inches long.The catheter met the requirements for patency and tensile testing.The catheter did not meet the requirements for leak testing due to a hole in the catheter between the thirteen and fourteen marks.It is unknown how or when this damage occurred.The instructions for use cautions, ¿low tear strength is a characteristic of most unreinforced silicone elastomer material.Care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks or tears.¿ proteinaceous debris was observed on the interior of the catheter.The instructions for use cautions, ¿obstructions may occur in any component of the system due to plugging by brain fragments, blood clots and tumor cell aggregates at some point along its course.¿ 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: 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: 8751002
• Report Number: 2021898-2019-00263
• Device Sequence Number: 2338879
• 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): 09/26/2019

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: 03/31/2023
• Device Model Number: 27703
• Device Catalogue Number: 27703
• Device Lot Number: E45905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR