MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY PERITONEAL CATHETER, SMALL LUMEN; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	43555
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2018
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 the catheter was broken during the procedure.There was no injury to the patient.
Additional Manufacturer Narrative
The returned catheter was patent and met the requirement for leak testing.Approximately 16.5 cm of the peritoneal catheter was returned.The catheter was broken / torn at the distal end.The catheter was tied at two points below the boot on the proximal end of the catheter.The boot tubing interface was broken and jagged in several places.Proteinaceous debris was observed on the exterior and interior of the catheter.It is unknown how or when the damage to the proximal end occurred.The instructions for use that accompany the product states, ¿care must be taken in the routing of catheters to prevent kinking and needless abrasion along their course.Abrasion can result in premature catheter failure (fracture).¿; and that ¿care must be taken during the procedure to avoid putting cuts, punctures and holes in the catheter.¿ it also states, ¿use of sharp instruments while handling these devices can nick or cut the silicone elastomer,¿¿.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, SMALL LUMEN
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7813243
• Report Number: 2021898-2018-00424
• Device Sequence Number: 856772
• Product Code: JXG
• UDI-Device Identifier: 00643169466807
• UDI-Public: 00643169466807
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K073139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 43555
• Device Catalogue Number: 43555
• Device Lot Number: E39245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1