MAUDE Adverse Event Report: PENDRACARE INTERNATIONAL B.V. CONVEY; CATHETER, PERCUTANEOUS

Model Number 6FCONVEY CLS3.5

Device Problem Material Deformation (2976)

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

Event Date 08/11/2020

Event Type  malfunction  

Event Description

Elderly female with coronary artery disease (cad).When obtaining the catheter for the cardiac cath, angioplasty and stent, the tubing was crimped in the middle and unusable for the procedure.No known harm to patient.

• Brand Name: CONVEY
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): PENDRACARE INTERNATIONAL B.V.; 7205 laketree dr; raleigh NC 27615
• MDR Report Key: 10514002
• MDR Text Key: 206312065
• Report Number: 10514002
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6FCONVEY CLS3.5
• Device Catalogue Number: H749392645740
• Device Lot Number: 1909-0044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Weight: 101