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

Catalog Number NCEUP3512X

Device Problems Inflation Problem (1310); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/01/2017

Event Type  Injury  

Event 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.

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: NC EUPHORA RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6596424
• MDR Text Key: 76127939
• Report Number: 9612164-2017-00635
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169396340
• UDI-Public: 00643169396340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR