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

Catalog Number NCSP3015X

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2022

Event Type  Injury  

Event Description

An attempt was made to use one nc sprinter rx ptca balloon catheter to treat a moderately tortuous, slightly calcified lesion with 85% stenosis located in the mid to proximal left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The balloon was inflated to 18 atm.It was reported that after subsequent inflations there was balloon deflation difficulties.The b alloon would not deflate at the lesion site.It was detailed that due to the deflation difficulties it was difficult to remove the balloon, and a balloon burst then occurred.After the balloon burst the body of the balloon disintegrated and the marker bands fell off.The balloon and all fragments were removed completely from the patient.Two non-medtronic stents were deployed overlapped on each tier in the connected ends in the lesion.The patient is alive with no injury.

Manufacturer Narrative

Image review: two images were provided for review.The first image was of a section of the shelf carton.The lot number was not captured in the image however the device details on the label of the shelf carton match what was reported in the complaint file.The second image was of the distal section of the device.It appeared that a guide wire was loaded in the device and that there was a kink on the transition shaft.Given the quality of the image provided it was not possible to determine if deflation difficulties, detachment or burst occurred.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: it was not difficult to remove the protective sheath.It was not difficult to remove the packaging stylette.The device was being used to post-dilate a deployed stent.Resistance was not noted when advancing the device to the lesion.The device was not moved or repositioned while inflated.It was stated that no leak occurred and difficulties were not encountered not encountered when inflating the device.The marker tape was removed one with the balloon and the other was removed with the sheath.There was no difficulty in removing the balloon after the rupture.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

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,
• 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: 15426345
• MDR Text Key: 299932277
• Report Number: 9612164-2022-03415
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NCSP3015X
• Device Lot Number: 224091137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2022
• Date Device Manufactured: 04/01/2022
• 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