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

Catalog Number NCSP3012X

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149)

Patient Problems Myocardial Infarction (1969); Occlusion (1984); Injury (2348)

Event Date 09/10/2019

Event Type  Injury  

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 rx ptca balloon catheter to treat a non-tortuous, mildly calcified lesion located in the mid left anterior descending artery.There was no damage noted to the packaging.There were no issues noted when removing the device from the hoop.The device was not inspected.It was reported that the device would not deflate at the lesion site.It was indicated that the balloon could therefore not be removed and the patient immediately developed symptoms of myocardial infarction.The balloon was inflated at 18atm in order to remove it.The patient was reported to be alive with injury.

Manufacturer Narrative

The nc sprinter rx ptca balloon catheter was being used to post dilate a non-medtronic stent implanted in the lad exhibiting 80% stenosis, the rca was noted to exhibit 90% stenosis.There were no issues noted when removing the device from the hoop.No difficulties were noted when removing the protective sheath and packaging stylette from the device.No resistance was noted while advancing the device to the lesion.The device was not moved or repositioned in the lesion.When the balloon was pressurized, it was found that pressure slowed up when it reached 4 atmospheres, the balloon could not be inflated quickly.Then, after reaching 8 atmospheres, pressure could not be retracted after pumping back the pressure pump.The patient began symptoms of myocardial infarction due vascular occlusion.High pressure negative pressure pumping and a guide wire puncture to the balloon was performed in an attempt to remove the balloon.The balloon was ruptured and successfully withdrawn after the balloon was inflated to 18 atm.The patient was reported to be alive with injury.Contrast / saline ratio was 320mg / ml.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image analysis review: image is of the distal section of a poba device.The balloon appears to be inflated.The distal shaft material appears to have inflated and burst.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The deflation difficulty occurred after the first inflation.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.

Manufacturer Narrative

Product analysis:device decontaminated with cidex opa.The balloon folds were expanded on return and it was evident that the distal shaft ¿ proximal balloon bond material, proximal to the proximal marker-band had been inflated.There was no evidence of a balloon burst or a leak.Negative prep was preformed with no issues noted.The device was inflated to 6 atm¿s and was able to maintain pressure, the proximal balloon bond and inflation lumen/distal shaft and balloon inflated.Negative pressure was pulled, both the balloon and the distal shaft deflated within seconds with no issues.The balloon was re-inflated to 8 atm¿s, the distal shaft ¿ proximal balloon bond material burst longitudinally before reaching 8 atm¿s.Deformation was evident to the distal tip.The inner lumen was verified with no issues noted.Kinks were evident on the hypotube.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 9023283
• MDR Text Key: 158084185
• Report Number: 9612164-2019-03915
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2021
• Device Catalogue Number: NCSP3012X
• Device Lot Number: 216726926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 49