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

Model Number 27536

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the ventriculoperitoneal shunt procedure was performed by dorsal horn puncture by the physician, and the flow was checked during the operation.In order to check the valve function during the postoperative process, pumping of the reservoir was performed, and reservoir remained recessed.A revision was performed with suspicion of a ventral obstruction.Aneurysms had been performed multiple times, and the protein concentration seemed to be high.The contrast agent flow from the reservoir but remained stagnant near the neck.However, it was unknown whether the contrast agent flowed little by little, it could be confirmed intermittently on the ventral side by x-ray.

Manufacturer Narrative

The returned catheter was attached to the valve for (b)(4) with a suture.A string connected the catheter with another segment of a catheter.The catheter met the requirements for leak and patency testing.Therefore, the nature of the complaint could not be replicated by laboratory personnel.There was damage to one of the ends of the catheter.It is unknown how this damage occurred.The instructions for use cautions, ¿improper handling or use of instruments when implanting shunt components may result in the cutting, slitting, crushing or breaking of components.¿ proteinaceous debris was observed on the catheter.The instructions for use cautions, ¿shunt obstruction may occur in any of the components of the shunt system.The ventricular catheter may become occluded by particulate matter such as blood clots or brain fragments¿¿ 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
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine,ca, MN 92618 ; 7635263305
• MDR Report Key: 8846410
• MDR Text Key: 152799940
• Report Number: 2021898-2019-00301
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K951258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27536
• Device Catalogue Number: 27536
• Device Lot Number: E53963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention