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

Catalog Number NCSP27509X

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 11/21/2017

Event Type  Injury  

Event Description

It was reported that the physician was attempting to use an nc sprinter balloon to pre-dilate a moderately calcified mid rca lesion.No damage was noted to the nc sprinter's packaging and no issues were noted when removing the device from the hoop/tray.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.During the procedure, the device did not pass through a previously deployed stent.No resistance was encountered and no excessive force used during delivery.It was reported that the balloon was expanded slowly, at an atm of 18-20.The balloon burst on the 1st inflation.When the balloon was pulled out, the distal marker became unfastened and stayed in the mid rca.The physician attempted to rewire the vessel using a non-medtronic wire but could not remove the distal part of the marker from the vessel.The physician then measured acceptable timi iii flow in the vessel so no further intervention was attempted.

Manufacturer Narrative

A compliant balloon and a 2.75mm nc sprinter had been already used.(compliant balloon did not open fully, nc sprinter device broke and a new device was then introduced).Lot details updated.Product analysis: a 0.014inch guidewire was returned loaded in device.It was not possible to remove gw from device during analysis.The device was returned with blood visible in the balloon and inflation lumen.The balloon had torn in a radial pattern with 7mm of balloon material present distal to the proximal bond.The remaining balloon material and a section of the distal tip had detached.The balloon and tip material was jagged and uneven at the detachment site.Visual inspection confirmed only one marker remained on the inner shaft.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: 7205873
• MDR Text Key: 97751000
• Report Number: 9612164-2018-00104
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2019
• Device Catalogue Number: NCSP27509X
• Device Lot Number: 212999171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• 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
• Patient Outcome(s): Required Intervention