MAUDE Adverse Event Report: MEDTRONIC MEXICO SPRINTER LEGEND RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number SPL25015X

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a procedure an attempt was made to use one sprinter legend rx ptca balloon catheter.It was reported that balloon burst/ leak /rupture occurred.Contrast was leaking at the balloon area.No patient injury was reported.

Manufacturer Narrative

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

Manufacturer Narrative

The device was not used in the patient.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the device returned with contrast visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, liquid was observed exiting the balloon distal cone.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a short longitudinal tear on the balloon material immediately proximal to the balloon distal cone.The balloon material was jagged and uneven at the tear site.Deformation was evident to the distal tip.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINTER LEGEND RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9382526
• MDR Text Key: 186755588
• Report Number: 9612164-2019-04922
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K103095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2022
• Device Catalogue Number: SPL25015X
• Device Lot Number: 218583949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2019
• 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