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

Catalog Number NCSP32512X

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 06/08/2022

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 one nc sprinter rx ptca balloon catheter to treat a non-tortuous, mildly calcified lesion exhibiting 75% stenosis located in the mid circumflex (cx) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistancewas not encountered when advancing the device.Excessive force was not used during delivery.The nc sprinter balloon was being used to post dilate a stent.The device was not moved or repositioned while inflated.The device was not kinked and re-straightened during use.It was reported that a balloon burst / leak occurred during the first balloon inflation at 12 atm.It was also reported that a balloon body detachment occurred and the balloon material detached from the catheter during positioning at the lesion.The detached portion of the device was successfully removed from the patient using a snare and by pulling the devices out together.The patient was reported to be alive with no further injuries.

Manufacturer Narrative

Additional information: it was reported that a balloon burst / leak occurred during the first balloon inflation at 12 atm x 10 seconds.The detached portion of the device fell into the coronary artery.Then the non-medtronic guide wire was wound repeatedly.The detached portion of the balloon and the stent were successfully removed from the patient using a snare and removed by pulling the devices out together.The stent was a non-medtronic device.The circumflex branch was re-implanted with the stent.After the surgery the patient was transferred to ccu for observation.Image analysis: one image returned for analysis.Multiple devices evident in the image, a snare like device appears to have been used, a detached portion of a device, possibly the nc sprinter can be seen.From the image provided, it is not possible to clearly identify any of the devices.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

Product analysis summary: the device returned with a complete radial detachment of the balloon at the proximal bond, exposing the inner member.The distal markerband was dislodged from the inner member and did not return for analysis.The detached balloon material did not return for analysis.The distal shaft and core wire were twisted.Blood was visible in the inflation lumen.Leak/burst testing could not be performed due to the condition of the device.A complete radial burst occurred at the proximal end of the balloon.It appeared that the balloon bond expanded leading to the burst.The balloon material was jagged and uneven at the burst site.A section of the distal tip was detached.The material on the detachment site was jagged and uneven.No other damage evident to the remainder of the device.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: 14730623
• MDR Text Key: 294272036
• Report Number: 9612164-2022-02298
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NCSP32512X
• Device Lot Number: 223662653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• 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
• Patient Age: 81 YR
• Patient Sex: Male