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

Catalog Number NCSP3012X

Device Problem Leak/Splash (1354)

Patient Problems Hematoma (1884); Injury (2348); Vascular Dissection (3160)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that an nc sprinter rx ptca balloon catheter was used during a procedure to treat a moderately tortuous and calcified lesion exhibiting 60% stenosis in the mid left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed, no issues reported.The lesion was predilated using a sprinter legend balloon.A non-medtronic 38mm drug eluting stent was implanted.The nc sprinter balloon passed through previously deployed stent.Resistance was not encountered advancing the device to the lesion and excessive force was not used during delivery of the device.It was reported that during an attempt to use the nc sprinter balloon to post dilate the stent, a balloon leak or catheter leak was experienced.The device ha had not been moved or repositioned prior to the issue.The balloon was first inflated to 12 atms for 10 seconds, then inflated to 14-16 atms for 10 seconds on the second inflation.Then it was noted to be hard to inflate the nc sprinter past 16 atms on the third inflation.Then the contrast agent was noted to be leaking.This caused a hematoma in the distal left anterior descending (lad) artery due to dissection of the blood vessels.The cath lab worked for two hours to control the hematoma which was successfully controlled in the end.The nc sprinter balloon was redilated outside of the patient's body using a pump and it was found that the ejecting point and performance of the balloon were completely different to previous cases.It was then thought that the leak was due to balloon quality rather than operation or case related reasons.It was noted that the nc sprinter could still be inflated.The hole in the balloon was reported to be much smaller than a normal point could cause by calcification.A trace of water was found ejecting upwards outside the balloon.The point on the balloon at which the leak was noted at was on the balloon shoulder, not within the working length of a balloon.

Manufacturer Narrative

Ivus analysis: transversal and longitudinal intravascular ultrasound images (photos) of the mid left anterior descending (lad) artery were reviewed.From the images provided the tortuous anatomy of the lad artery can be confirmed.Calcified lesions can be confirmed and the form of the irregular, sharp, calcified spikes can be observed from provided longitudinal ivus images.Dissection is visible from the provided transversal ivus images, taking the form of the characteristic dissection arm extending into the medial space.Hematoma in the distal lad can be confirmed from provided transversal ivus images.Cine image analysis: images provided were pictures/videos of screens, which resulted in poor image quality.An occlusion is visible, and a device was advanced to the lesion.Still image analysis: image shows liquid exiting the balloon.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 9537564
• MDR Text Key: 173699105
• Report Number: 9612164-2020-00011
• 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: 04/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2022
• Device Catalogue Number: NCSP3012X
• Device Lot Number: 217535768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2020
• Date Device Manufactured: 04/17/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 116