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

Catalog Number	NCEUP37515X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the device returned with a detachment on the hypotube approx.57cm distal to the strain relief.The hypotube material was jagged and oval on both sides of the hypotube.Numerous kinks were evident on the hypotube both proximal and distal to the detachment site.The balloon returned deflated with hardened residue present inside.Blood was visible in the inflation lumen and balloon.Deformation was evident to the distal tip.The balloon was inflated to 12 atm (nominal pressure) with no issues noted.
Event or Problem Description
The physician intended to use an nc euphora balloon catheter to treat a mildly tortuous, severely calcified lesion with 95% stenosis in the proximal lad.The patient has a known history of cad.There was no damage noted to 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 lesion was pre-dilated.During advancement through the guide catheter the device fractured.Balloon had previously been used to post dilate.Stent needed further post dilation, so balloon was loaded on guidewire, advancement was attempted but it was noted that the physician couldn¿t see distal balloon advancing under fluoro despite proximal shaft being advanced.When the physician looked in the guide catheter, it was seen that there was no advancement of the distal despite advancing proximal shaft.Pulled negative and noted blood rushing back into inflation device.Attempted withdrawal and proximal shaft came out of guide and distal portion remained in guide catheter.It is reported that the device fractured within guide catheter.The detachment occurred near the middle of the shaft.A 2.5x15 sc euphora was used as a trap balloon to secure the fractured catheter inside the guide and then removed the entire system.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.The procedure was completed with another nc euphora of the same size.

• 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: 6783863
• Report Number: 9612164-2017-01078
• Device Sequence Number: 16521219
• Product Code: LOX
• UDI-Device Identifier: 00643169396272
• UDI-Public: 00643169396272
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 07/11/2017

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: 04/15/2019
• Device Catalogue Number: NCEUP37515X
• Device Lot Number: 213150932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR