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

Catalog Number EUP2530X

Device Problem Deflation Problem (1149)

Patient Problem Vascular Dissection (3160)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The euphora balloon was inflated to 18 atms in the proximal lad, lesion had moderate tortuosity and moderate calcification.The balloon was inflated once and when an attempt was made to deflate the balloon it would not deflate.The balloon was removed, partially deflated causing a dissection of the lad.The physician implanted a drug-eluting stent to treat the dissection.That patient has already recovered and back to home.No damage had been noted to the balloon packaging.The device was inspected prior to use with no issues noted.Negative prep was not performed.The balloon did not pass through a previously deployed stent.Resistance was encountered when advancing the device, excessive force was not applied.The balloon was not moved or re-positioned in the vessel while inflated.The physician used the inflation to try to deflate the balloon after it was noted it couldn't deflate fully.

Manufacturer Narrative

Device evaluation: the balloon returned deflated.The balloon bond was stretched.It was not possible to inflate the balloon to perform deflation time testing due to stretching.The distal shaft was kinked 5 cm proximal to the distal tip.No deformation was visible to the balloon material.No deformation visible to the distal tip.The guide wire lumen patency was not verified due to stretching photographic image review: five photos were received for evaluation.An image shows the distal end of the complaint device exiting the tip of the guide catheter.There is no deformation visible from this image.An image shows the luer of the complaint device connected to an accessory device.The size of the device matches what was reported.An image shows the balloon, luer and guide catheter.The luer is connected to an accessory device.There is what appears to be narrowing/stretching at the location of the proximal balloon bond.An image shows the distal end of the complaint device exiting the tip of the guide catheter.There is no deformation visible from this image.An image shows the inflation device, guide catheter, complaint device and assembly system.No damage is visible to the device in this image.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: 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: 7777073
• MDR Text Key: 116905893
• Report Number: 9612164-2018-02027
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K143480
• 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: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2020
• Device Catalogue Number: EUP2530X
• Device Lot Number: 214781685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2018
• 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: 77 YR