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

Model Number NCSP27515X

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Difficult to Remove (1528); Device Damaged by Another Device (2915)

Patient Problems Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160); Insufficient Information (4580)

Event Date 10/08/2023

Event Type  Injury  

Event Description

An attempt was made to use one nc sprinter balloon catheter to treat a lesion.The device was being used to post-dilate the proximal and middle anterior descending coronary artery stent.The device was inflated to 12 atm.It was reported that after 5 seconds of expansion the pressure pump pumped back, but the balloon did not retract and could not be withdrawn.After repeated retractions the balloon still could not retract.The blood pressure dropped.To avoid malignant arrhythmias the pressure pump was slowly increased to 20 atm and the balloon was burst.Angiography was performed again, and it was found that the blood flow in the anterior descending artery was timi grade 3.The stent at the proximal end of the original balloon was partially broken.The artery at the fracture of the stent segment was slightly dilated, and the contrast agent was locally retained for a short period of time.A small dissection could not be ruled out.No further patient injury reported.

Manufacturer Narrative

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.

Manufacturer Narrative

Additional information: the device was inspected before use with no issues noted.It was not difficult to remove the protective sheath or the packaging stylette.Negative prep/purging was performed on the device prior to use with no issues noted.Resistance was not noted while advancing the device to the lesion.Excessive force was not used.A 1:1 ratio was used for the concentration of contrast/saline.No difficulties were noted during inflation of the device.Deflation difficulties were noted after the first inflation.The device was not moved or repositioned while inflated.The balloon failed to deflate.Sufficient time was given to the balloon to be deflated prior to the attempt to remove.It was assessed that the cause of dissection is relevant to the use of the device.The patient is healthy.Annex d code.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.

Manufacturer Narrative

Additional information: the balloon was burst to restore the flow.The balloon was then successfully retrieved, but the stent at the proximal end of the strut original drug eluting stent was partially broken.It is unknown if the stent fracture was caused by the balloon directly, or the retrieving process.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: NC SPRINTER RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18037295
• MDR Text Key: 326905003
• Report Number: 9612164-2023-04919
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NCSP27515X
• Device Catalogue Number: NCSP27515X
• Device Lot Number: 227007648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• Date Device Manufactured: 07/21/2023
• 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; Other
• Patient Age: 66 YR
• Patient Sex: Male