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

Catalog Number SPL25020X

Device Problems Deflation Problem (1149); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the distal tip was slightly flared.There were numerous kinks visible along the hypotube.The balloon was inflated to 14atms (rate burst pressure) in a time of 4.50 seconds and deflated in a time of 4.06 seconds.Specification is less than or equal to 15 seconds.(b)(4).

Event Description

The physician was attempting to use a sprinter legend balloon during a procedure to treat a lesion in a moderately tortuous lad.The lesion exhibited moderate calcification.There was no damage to packaging, or issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was performed with no issues noted.During the procedure the balloon would not deflate at the lesion site.Multiple attempts to deflate were made with the indeflator and vac loc.The balloon was deflated with vac loc after multiple tries.The device did not pass through a previously-deployed stent.No resistance was encountered and no excessive force was used.No patient injury reported.

Manufacturer Narrative

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: 5888335
• MDR Text Key: 52493626
• Report Number: 9612164-2016-00870
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2018
• Device Catalogue Number: SPL25020X
• Device Lot Number: 210025653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2015
• 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