MAUDE Adverse Event Report: COVIDIEN LLC CSF-VENTRICULAR PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTR

Model Number 44010

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the operation, it was found that the catheter at the end of the ventricle was broken.This did not result in a procedure delay and backup products were used to complete the procedure.The patient's status was alive-no injury.

Manufacturer Narrative

The returned ventricular catheter arrived in two broken parts.It is unknown how this damage may have occurred.The catheters did not meet requirements for leakage testing.The ifu cautions the user, "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." if information is provided in the future, a supplemental report will be issued.

• Brand Name: CSF-VENTRICULAR PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTR
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12701251
• MDR Text Key: 278615211
• Report Number: 9612501-2021-01769
• Device Sequence Number: 1
• Product Code: LKG
• UDI-Device Identifier: 00763000030292
• UDI-Public: 00763000030292
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K874468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 44010
• Device Catalogue Number: 44010
• Device Lot Number: 0220188369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2020
• 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