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

Catalog Number NCEUP4006X

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/20/2017

Event Type  Injury  

Manufacturer Narrative

Image review: three still images were provided for review.The first image captures the complaint device with inflation contrast visible in the balloon.The second image captures what appears to be the complaint device in vivo.However this cannot be confirmed as the quality of the image is poor.The third image captures the complaint device and the packaging label on the device.The manufacturing lot number is not visible in the photo.The reported deflation difficulties cannot be confirmed by the images received.(b)(4).

Event Description

It was reported that the physician was attempting to use a nc euphora rx balloon to treat a non-tortuous mid vessel lesion.No damage was noted to device packaging and no issues removing the device from the hoop/tray.The device was inspected and negative prep was performed with no issues noted.During advancement of the balloon resistance was reported but no excessive force was used.It was reported that the balloon was being used and was inflated post stent dilatation, however was unable to be deflated after the first inflation.Removal difficulties were also reported.The nc euphora balloon was removed after several attempts.There was an attempt to perforate the balloon using a wire.No patient injury reported.

Manufacturer Narrative

Device evaluation: the balloon returned inflated with crystallised residue present inside the balloon.It was not possible to deflate the balloon there was no stretching evident to the distal shaft or balloon bond.No other damage visible to the catheter.The device was placed in the waterbath to disperse the residue in the balloon in order to aid inflation.Inflation testing was performed, but balloon failed to inflate.The device was inspected for any stretching on the distal shaft however no stretching was evident.The delivery system was placed in waterbath to loosen any potential blockages.Upon second inflation, balloon again failed to inflate.To determine location of blockage, delivery system was cut at the distal shaft 21.6cm proximal to the distal tip.A make shift luer was attached to the distal potion of the device which included the distal shaft and the balloon.Using a make-shift luer, the balloon was successfully inflated at 12 atms, at 13 secs.A 0.014 inch mandrel was advanced through the hypotube with no resistance noted.There appeared to be a blockage in the transition tube, as no water was seen exiting when pressurisation was applied.The transition shaft was cut away to determine the location of the blockage.Crystallized contrast residue was visible under the transition tubing material and on the support wire.The device was placed into the waterbath to disperse residue.Upon second attempt water was successfully flushed through hypotube, with no issues noted.This confirmed the blockage to be due to the crystallised residue.The guidewire lumen patency was verified with a 0.015 inch mandrel.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: 7185171
• MDR Text Key: 97053246
• Report Number: 9612164-2018-00059
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NCEUP4006X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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