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

Model Number	NCEUP32515X
Medical Device Problem Codes	Burst Container or Vessel (1074); Deflation Problem (1149)
Health Effect - Clinical Codes	Injury (2348); Insufficient Information (4580)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure, an attempt was made to use one nc euphora rx ptca balloon catheter to treat a mildly tortuous, moderately calcified lesion exhibiting 95% stenosis located in the mid left anterior descending (lad) artery.The device was inspected with no issues noted.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that balloon deflation difficulties occurred and the device would not deflate at the lesion site.It was stated after trying numerous times to deflate the balloon with the inflator and syringes, the balloon had to be overinflated and burst for removal.Total inflation time in the lad was 5 minutes.The patient was reported to be alive with no further injuries.
Additional Manufacturer Narrative
Additional information: no difficulties were noted when removing the protective sheath or the packaging stylette.The device was not moved or repositioned while inflated.The concentration of contrast/saline used was 50/50.Negative prep was performed prior to use with no issues noted.14 atm of pressure was applied on initial inflation, the balloon was inflated to 30 atm for it to burst.The balloon was then removed over the wire.It was stated there were failed attempts to burst the balloon using another wire and microcatheter.It was later stated that the wire and microcatheter used to attempt to burst the balloon were both non medtronic 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.
Additional Manufacturer Narrative
Device evaluation summary: device returned for evaluation.The balloon bonds were open and hardened contrast was present in the balloon.The device was immersed in a water bath to disperse the contrast.It was not possible to inflate the balloon after it was immersed in a water bath.The cause for the inability to inflate was determined to be slight necking to the proximal balloon bond.Therefore, it was not possible to perform inflation/deflation testing on the device or locate the burst on the balloon.The inner lumen patency was verified with a 0.015 inch mandrel.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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10725207
• Report Number: 9612164-2020-04066
• Device Sequence Number: 3180481
• Product Code: LOX
• UDI-Device Identifier: 00643169395794
• UDI-Public: 00643169395794
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2022
• Device Model Number: NCEUP32515X
• Device Catalogue Number: NCEUP32515X
• Device Lot Number: 220538004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 10/23/2020; 01/25/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/18/2020; 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 70