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

Catalog Number	NCEUP4012X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An attempt was made to use two nc euphora balloon catheters to treat a moderately tortuous and calcified lesion exhibiting 70% stenosis located in the proximal-mid diagonal branch of the lad using the kissing balloon technique.Both devices were inspected with no issue.Negative prep was performed with no issue.The lesion was pre-dilated.Excessive force was not used during delivery of either device.An attempt was first made to use the 4.0mm balloon to treat the lesion.The device passed through a previously deployed stent.Resistance was not encountered when advancing the device.The 4.0mm balloon was passed through the guide and was in the lad stent.An attempt was then made to pass the 2.5mm balloon however resistance was encountered.The 4.0mm balloon was pulled back and everything was pulled out in the guide, however it was indicated that a detachment occurred at the balloon during removal.The detached portion of the device was removed in the guide.The patient is reported to be alive with no injury.
Additional Manufacturer Narrative
The 4.0mm balloon was passed through the 6 french non-medtronic guide.It was reported that the balloon catheters were not pushed hard.The 4.0mm balloon was inflated with no issues noted.No difficulties were noted during deflation of the balloon and the balloon was left to deflate fully before attempting to remove it.No additional intervention was needed to recover the 4.0mm balloon.Nothing was left in the patient.No issues were reported for a resolute onyx stent used during the procedure.There was no damage caused to the 4.0mm balloon by any medtronic device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: the device returned with a detachment on the transitional tubing.The detached portion of the device was attached to the 2.5mm*12mm device.It was possible to remove the detached portion of the device from the 2.5mm*12mm device.There was 10cm of the support wire exposed distal to the detachment site.The transitional tubing material was jagged on both sides of the detachment site.The inflation lumen and guidewire lumen were torn.There was no damage evident to the remainder of the device.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: 8296054
• Report Number: 9612164-2019-00389
• Device Sequence Number: 2575213
• Product Code: LOX
• UDI-Device Identifier: 00643169396227
• UDI-Public: 00643169396227
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 04/24/2019

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: 07/05/2020
• Device Catalogue Number: NCEUP4012X
• Device Lot Number: 215799703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 01/31/2019; 04/09/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 02/28/2019; 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 118