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

Catalog Number NCSP27512X

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

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 a nc sprinter ptca balloon catheter to treat a mildly calcified and tortuous lesion exhibiting 90% stenosis located in the proximal left anterior descending artery (lad).The device was inspected and negative prep was performed with no issues noted.The lesion was pre dilated.The device did pass through a previously deployed stent.It was reported that a balloon burst /leak occurred.There were no issues on the first inflation.On the second inflation to 13 atms, blood returned to the pressure pump and a drop in pressure was noted.The patient is alive with no injury.

Manufacturer Narrative

Image review: a still image was received.In the image, liquid appears to be exiting the distal shaft of the device.It appears that blood is visible in the balloon inflation lumen.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device analysis: the balloon folds were expanded.The device returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, liquid was observed exiting the balloon.The balloon failed to maintain pressure.Upon visual inspection of the device, there was small round tear on the balloon material in the mid-section of the balloon.The balloon material was jagged and uneven at the tear site.Deformation was evident to distal tip.Kinks were evident to the distal shaft.Bunching was evident to the transition shaft.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: 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: 9415549
• MDR Text Key: 186868694
• Report Number: 9612164-2019-05015
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2021
• Device Catalogue Number: NCSP27512X
• Device Lot Number: 216364403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2018
• 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 Age: 49 YR
• Patient Weight: 59