MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY PERITONEAL CATHETER WITH BIOGLIDE AND 8 SLITS; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	27536
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 the catheter was implanted in 2016 and it fractured in the abdominal cavity.It was stated the broken pieces were retrieved.The fragments were removed by using an endoscope.Additional information received reported that a replacement procedure was performed because there was a clog in the shunt system which was implanted in 2016.A ct scan after the replacement procedure confirmed broken piece(s) of the catheter within the peritoneal cavity.The broken piece(s) was part of the catheter which was implanted in 2016.It was noted that the patient was a child.
Additional Manufacturer Narrative
Fifteen inches of the peritoneal catheter was returned.A patency and leak test were not performed due to proteinaceous debris found on the proximal end of the catheter.The tensile test was not performed due to less than 20 inches of the catheter being returned.There was damage and proteinaceous debris in/on the proximal end of the broken catheter.The instructions for use cautions, ¿low tear strength is a characteristic of most unreinforced silicone elastomer materials.Care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks, or tears.¿ 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: PERITONEAL CATHETER WITH BIOGLIDE AND 8 SLITS
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8299373
• Report Number: 2021898-2019-00046
• Device Sequence Number: 1946745
• Product Code: JXG
• UDI-Device Identifier: 00643169472808
• UDI-Public: 00643169472808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951258
• 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): 03/15/2019

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: 01/31/2021
• Device Model Number: 27536
• Device Catalogue Number: 27536
• Device Lot Number: E12039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 03/15/2019
• 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