MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC,

Catalog Number 28M330155302290U

Device Problem Physical Resistance (2578)

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

Event Date 04/01/2014

Event Type  malfunction  

Manufacturer Narrative

"during an internal audit, it was determined that complaints for similar devices, and device malfunctions that have the potential to harm the patient if they were to recur, were not reported as per fda guidance.After retrospective review, this event is determined to be mdr reportable.".

Event Description

"during advancing the inner sheath toward zone 3 (with the position #1), the doctor felt the resistance.Then, the resistance was encountered again when he tried to pull the handle in the position #2 to deploy the stent graft at the implanting site.He managed to deploy it and the operation was successfully done.After the procedure, the doctor tried the same operation of the removed unit, and the resistance was still encountered and the motion of this unit was not smoother than usual.".

• Brand Name: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
• Type of Device: STENT, ENDOVASCULAR GRAFT, AORTIC,
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• Manufacturer Contact: mr. stark ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 7314758
• MDR Text Key: 101851580
• Report Number: 2247858-2018-00016
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 28M330155302290U
• Device Lot Number: 131015155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2014
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 03/05/2018
• 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