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

Catalog Number EUP2020X

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/31/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was intended to use one euphora rx balloon to treat a mildly calcified and non tortuous lesion in proximal, mid and distal portions of the lad with 50-70% of stenosis.It was reported that there was no damage noted to the packaging and no issues were identified when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was not pre-dilated.The euphora rx balloon device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.It was reported that balloon deflation difficulties were encountered as the euphora rx balloon was slow to deflate at the lesion site during subsequent inflation.It was also reported that the euphora rx balloon burst.The balloon had been inflated maybe 2-3 times as routine and nominal pressure was applied prior to the burst occurring.A stent pci was required.The patient is alive with no injury.

Manufacturer Narrative

Additional information: the protective sheath and packaging stylette were removed without difficulty.The euphora rx balloon was intended to be used to pre-dilate the lesion.There were no difficulties noted during balloon inflations.On removal, it was reported that the balloon got caught on the wire and they had to be removed together.No attempt was made to intentionally burst the balloon by increasing the inflation pressure to the balloon when the deflation difficulties 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

Product analysis: kinks were noted on the hypotube.Balloon folds were open.The device passed negative prep.No damage was noted to the proximal balloon bond.It was not possible to load a guidewire or mandrel through the lumen, the wire advanced to approx.15.2cm distal to the exchange joint.Narrowing of the inner member was noted at approx.7.5cm, distal to the exchange joint, however the guidewire advanced through this point.The balloon was inflated to nominal pressure of 12atm and maintained pressure with no issues noted.The balloon deflated in 6sec with no issues noted.No deflations difficulties or bursts were identified on the device.No other damage was noted to the remainder of the device.Additional information: a non-medtronic inflation device was used for balloon inflation.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 had been inflated around 4-5 times as routine, and only nominal pressure was applied prior to the burst occurring.It was a non-medtronic wire that the balloon got caught on, on removal.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: 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12149670
• MDR Text Key: 260964335
• Report Number: 9612164-2021-02687
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/29/2021

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: 10/08/2022
• Device Catalogue Number: EUP2020X
• Device Lot Number: 220928373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/12/2021
• Supplement Dates Manufacturer Received: 07/19/2021; 10/20/2021; 11/18/2021
• Supplement Dates FDA Received: 08/11/2021; 11/15/2021; 11/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/08/2020
• 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): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female