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

Catalog Number NCEUP3512X

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician attempted to use an nc euphora balloon to treat a lesion in the rca.No damage noted to packaging and no issues removing the device from the hoop/tray.Device was inspected with no issues noted.It is reported that a balloon burst/leak occurred during the first balloon inflation to 30 atms.Device passed through a previously deployed stent.It is also reported that a the catheter detached during removal.The detached portion remains in vivo.An unsuccessful attempt was made to snare the detached portion.The device was subsequently removed in the operating room.Patient is alive with injury, patient went in for open heart surgery.

Manufacturer Narrative

The previously reported balloon was been used to treat instent restenosis in a heavily calcified lesion in a minimally tortuous mid rca.The device was being used to pre-dilate a restenosed stent.Negative prep was performed with no issue.No resistance was noted while advancing the device to the lesion.First inflation was at 15atm for 20 seconds.It is reported that a balloon burst/leak occurred during the second balloon inflation to 30 atms for 60 seconds.The device was not moved or repositioned prior to the burst.Device passed through a previously deployed stent.It is also reported that during removal, the catheter detached at the proximal end of the catheter, 37 centimeters from the balloon.Several attempts were made to snare the the balloon, but were unsuccessful.It is reported that there was no flow distal to the balloon.The device was subsequently removed in the or during a separate open heart surgery procedure.

Manufacturer Narrative

Evaluation summary: a stopcock was returned attached to the luer of the device.The device returned with a detachment on the balloon material 142.6cm distal to the strain relief.Numerous kinks were evident on the outer lumen.The balloon material was jagged and uneven at the detachment site.The inner lumen material had detached approx.0.5cm distal to the guidewire entry port bond.The detached distal portion of the inner lumen returned for analysis.The inner lumen material was jagged and uneven on both sides of the detachment site.The distal tip and one inner shaft marker had detached from the inner lumen and did not return for analysis.The detached inner lumen was severely stretched, bunched and kinked.Numerous kinks were evident along the transition tubing.Kinks were evident along the hypotube.Cine image review: the images capture a heavily calcified lesion site in the rca as reported by the account.Previously deployed stents are visible in the vessel.The attempted delivery of an unidentified balloon device is captured by the images.Multiple pre-dilatations were completed in the vessel.After ballooning in the mid rca contrast is visible proximal to the lesion site but there is no distal flow.This suggests that the detached material remains at the lesion site where it burst and is preventing flow to the distal vessel.

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: 6401956
• MDR Text Key: 69845478
• Report Number: 9612164-2017-00268
• 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,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2018
• Device Catalogue Number: NCEUP3512X
• Device Lot Number: 212015577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2016
• 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: 60 YR
• Patient Weight: 81