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

Catalog Number SPL25012X

Device Problems Fracture (1260); Leak/Splash (1354)

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

Event Date 02/24/2020

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 to treat a lesion.It was reported that the balloon leaked during balloon inflation.It was stated that the balloon wouldn¿t inflate.When the balloon was removed from the guide catheter, an attempt was made to try to inflate the device again and contrast was noticed coming out of the tip of the balloon.No patient injury was reported.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: an attempt was made to connect the luer of the sprinter to the non-medtronic inflation device.The sprinter device was not inspected prior to attaching the luer to the non-medtronic inflation device.No crack was noted prior to attaching the luer of the sprinter to the inflation device.It was reported that a crack may have been present on the sprinter legend before the balloon was attached to the indeflator, but it was impossible to be certain about it as the device was not inspected prior to connection.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: 9778536
• MDR Text Key: 190325182
• Report Number: 9612164-2020-00964
• 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
• Report Date: 05/28/2020

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 Expiration Date: 09/19/2022
• Device Catalogue Number: SPL25012X
• Device Lot Number: 218532034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 03/10/2020; 05/27/2020
• Supplement Dates FDA Received: 03/26/2020; 05/28/2020
• Date Device Manufactured: 09/20/2019
• 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