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

Catalog Number	NCEUP3512X
Medical Device Problem Codes	Inflation Problem (1310); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the physician was attempting to treat a non-calcified and non-tortuous proximal lad lesion exhibiting 80% stenosis.It was reported that a nc euphoria balloon was selected.Damage was noted to the outer carton.No damage was noted to the device packaging.Issues were encountered removing the device from the hoop/tray.It was reported that the stylet was difficult to remove but came out with no noticeable damage to the balloon.The device was inspected and negative prep performed with no issues noted.The lesion was pre-dilated.During delivery the device passed through a previously deployed stent.No resistance was encountered when advancing the device or excessive force used.The balloon did not inflate and dye was seen streaming into the cx artery.The physician pulled negative on the inflation device and no blood was present in the indeflator.An attempt was made to remove the balloon but only the back shaft of the catheter came out.The balloon remained in the proximal lad.The physician advanced a non-mdt wire into the guide catheter and positioned the tip in the distal 1/3 of the guide.A non-mdt catheter was used over the inserted wire and was inflated to 20 atm inside the guiding catheter to trap the detached nc euphoria catheter.The balloons, wires and guiding catheter was removed together as one unit successfully.The nc euphoria balloon was inspected and appeared to be intact at the balloon tip.
Additional Manufacturer Narrative
The device was returned for analysis.The nc euphora device returned inside the boston scientific guide catheter.It was necessary to cut the guide catheter in order to remove the detached distal portion of the nc euphora delivery system.The device was detached on the hypotube, 76.4cm proximal to the distal tip.The luer and approximately 65cm of the hypotube were not returned.The hypotube material was jagged and oval on the detachment site.No residue was present in the inflation lumen or balloon.Balloon folds are closed and intact.Kinks were evident on the hypotube at 5.4cm and 17.5cm distal to the detached site.The distal tip was slightly flared.There is blood visible on the distal tip.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.

• 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: 6596424
• Report Number: 9612164-2017-00635
• Device Sequence Number: 369907
• Product Code: LOX
• UDI-Device Identifier: 00643169396340
• UDI-Public: 00643169396340
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/17/2017

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: 03/29/2019
• Device Catalogue Number: NCEUP3512X
• Device Lot Number: 213055694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 07/17/2017; 07/17/2017
• Initial Report FDA Received Date: 05/29/2017
• Supplement Report FDA Received Date: 08/14/2017; 09/07/2017
• 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: 75 YR