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

Model Number	NCEUP3020X
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: resistance was encountered during delivery and withdrawal of the nc euphora balloon catheter.Sufficient time was given to allow the balloon to fully deflate prior to attempting removal.Product analysis summary: the device returned with a detachment on the hypotube distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.No kinks were evident on the hypotube.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A nc euphora rx ptca balloon catheter was used during a radial approach to treat a mildly calcified, severely tortuous lesion in the distal left anterior descending (lad) artery.A 6 fr launcher guide catheter and a 6 fr guide liner were used over a non-medtronic wire.There was no damage noted to device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was performed with no issues.The device was kinked and re straightened during use.The lesion was pre dilated.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that the device detached at the hub inside the guide liner during removal difficulties following balloon inflation.It was also reported that excessive force was used to pull the balloon catheter out due to the site being extremely tortuous.The patient was reported to be alive with no injury.

• 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: 9693621
• Report Number: 9612164-2020-00672
• Device Sequence Number: 1809967
• Product Code: LOX
• UDI-Device Identifier: 00643169395848
• UDI-Public: 00643169395848
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2021
• Device Model Number: NCEUP3020X
• Device Catalogue Number: NCEUP3020X
• Device Lot Number: 217645099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR