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

Catalog Number NCEUP32515X

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problems Non specific EKG/ECG Changes (1817); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 11/08/2022

Event Type  Injury  

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.

Event Description

During a procedure an attempt was made to use one nc euphora rx ptca balloon catheter to treat a mildly tortuous and moderately calcified lesion in the mid lad.The device was inspected with no issues noted.Negative prep was performed with no issues.During device preparation no issues were experienced with removal of the sheath and stylette, or removal from the hoop.The lesion was predilated.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used.The device was not kinked and restraightened during use.It was reported that a balloon burst occurred during the first inflation at 20 atm when post dilating a 3mm x 48mm non-medtronic stent.When removing the burst balloon from the patient a detachment of the catheter also occurred.Resistance was encountered during use with a non-medtronic guide catheter.It was therefore decided to remove all devices together; the angiographic guide wire, guide catheter and the nc euphora balloon catheter.Upon removal, it was noted that the whole catheter part (blue part) was missing from the balloon delivery system and the catheter was found entangle with the angiographic guidewire.Upon flushing the guide catheter with saline, the balloon portion of the catheter was not found to be present in the guide catheter.The patient experienced st elevation, and was sent for a ct scan.The detached portion of the balloon catheter could not be seen during imaging.The same day the patients st level was back to normal with timi flow 3.The patient remained in hospital for one additional day for further observation.There was no issues experienced with inflation of the nc euphora balloon.There was no issue with the time taken to fully inflate the balloon and there was no air present in the balloon.There was no anomalies visualized on fluoroscopy with the shaft or proximal side to the balloon before the burst occurred.The patient i s alive with no further injury.

Manufacturer Narrative

Correction: a set of procedural videos were provided for review.The images confirm that the lad was stented from proximal to distal vessel.What appeared to be the nc euphora balloon was delivered and positioned to post dilate a deployed stent in the mid-lad.On pressurisation of the balloon contrast can be seen exiting the proximal end of the balloon/distal inflation lumen area.The images were checking that no injury was caused to vessel as a result of the burst.The nc euphora balloon appears to have been pulled back to the tip of the guide catheter.The vessel remained patent post balloon burst and removal of the nc euphora.The images filed to identify the root cause of the balloon burst.The device was received in two (2) parts).The proximal point of detachment was immediately distal to the wire entry port (exchange joint) and the distal point of detachment was under the balloon cone at the proximal end of the tip tubing.The detachment sites were stretched, jagged and uneven.It appeared that the balloon bond/distal inflation lumen expanded leading to the radial burst.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: a kink was evident on the hypotube immediately distal to the strain relief.The device returned with a total detachment of the inner member.It appeared that the detachment occurred distal to the exchange joint.The detachment site was jagged and uneven.The detached inner member returned stretched, kinked, and flattened.A detachment of the tip was also evident and did not return for analysis.Detached tip site was jagged and uneven.Both proximal and distal marker bands were not positioned on the inner member.The marker bands did not return for analysis and their location is unknown.A total radial balloon burst occurred approx.23cm distal to the exchange joint.It appeared that the balloon bond expanded leading to the burst.No other damage evident to the remainder of the device.Additional information: the missing part was not radio opaque so technically nothing could be seen.Everywhere was searched under fluoroscopy since they were trying to identify the balloon via balloon marker.Correction: three images were provided for review.The first image shows the shelf carton, hoop and device.The lot number 222097200 and the device details on the label of the shelf carton match what was reported in the complaint file.There appears to be a detachment evident on the device.The second image shows the distal section of the device where it appears a balloon burst is evident.It appears a complete radial burst occurred, and the balloon material, distal of the burst site is not present.The inner member can be seen detached and separate from the rest of the device, no longer positioned inside the outer shaft.It appears the detachment occurred distal of the exchange joint.It also appears that a detachment of the distal tip occurred.The third images show a close up of the burst site, however the image is unclear.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 EUPHORA 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: 15860043
• MDR Text Key: 304285877
• Report Number: 9612164-2022-04393
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K141090
• 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: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2023
• Device Catalogue Number: NCEUP32515X
• Device Lot Number: 222097200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 11/24/2022
• Supplement Dates Manufacturer Received: 12/08/2022; 01/06/2023
• Supplement Dates FDA Received: 01/08/2023; 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2020
• 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): Hospitalization