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

Catalog Number NCSP4012X

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician intended to use an nc sprinter balloon catheter to treat a lesion in the ostium of the left main coronary artery.There were no abnormalities in relation to anatomy.The lesion was pre-dilated.The device passed through a previously-deployed stent.The device was being used to post-dilate the stent.It is reported that the balloon got stuck on the stent after the stent was deployed.The balloon was fully deflated prior to attempting to remove the device.The stent was then removed from the patient using the balloon.It was reported that no force was used to remove the balloon.No further intervention was required to remove the balloon or the stent from the patient.No damage was reported to the stent upon its removal.No patient injury was reported.

Manufacturer Narrative

Additional information: the device was being used to post-dilate a newly deployed medtronic stent (model unknown).No damage was done to the artery walls when the stent was removed using the nc sprinter balloon catheter.The balloon did not get stuck on the previously deployed stent during advancement before reaching the target stent.No further stenting was required.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the nc sprinter device was being used to post-dilate a new non-medtronic stent.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NC SPRINTER 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: 7116339
• MDR Text Key: 95068237
• Report Number: 9612164-2017-01931
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P790017
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2020
• Device Catalogue Number: NCSP4012X
• Device Lot Number: 213125129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2017
• 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