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

Catalog Number EUP3515X

Device Problem Deflation Problem (1149)

Patient Problems Occlusion (1984); Thrombus (2101)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a procedure an attempt was made to use a euphora rx ptca balloon catheter to treat a mildly tortuous mildly calcified lesion located in the mid left anterior descending artery (lad).It was reported that there were balloon inflation difficulties during balloon inflation and also deflation difficulties encountered when attempting to deflate at the lesion site.Deflation attempts were made many times before deflation could be done.It was indicated that there was an occlusion with no lad distal flow.Distal flow was then observed however cine images show a haziness.The patient was reported to be alive with no further injury.

Manufacturer Narrative

No difficulties were noted when removing the protective sheath.The lesion was pre-dilated.No resistance was noted advancing the device to the lesion.Excessive force was not used.The balloon partially inflated.The balloon finally deflated.The physician assessed that the reported haziness was an issue with the balloon.Image review: photo 1; an image provided shows a lesion in the lad.There was no other information provided in the image related to the reported event.Photo 2; an image provided shows a portion of a shelf carton.The lot number on the label of the shelf carton corresponds with the lot number reported in gch.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Images provided show the inflation of a balloon across the lesion.The balloon does not appear to have been adequately purged or air during reparation as there is air in the mid to distal balloon.Post deflation of the balloon appear to show occlusion in the vessel at the proximal end of the vessel.Subsequent images appear to show the presence of a thrombus in the vessel.This is the most likely reason for the vessel occlusion.There is no evidence to confirm the deflation difficulties or the root case of the inflation /deflation issues.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: there is no evidence to confirm the deflation difficulties or the root case of the inflation /deflation issues.The distal end of the balloon appears to be filled with air during inflation and only the proximal end of the balloon shows the presence of contrast.The images fail to provide a root cause for the issues encountered.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: 9150126
• MDR Text Key: 161085951
• Report Number: 9612164-2019-04207
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 03/31/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2021
• Device Catalogue Number: EUP3515X
• Device Lot Number: 217601085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 10/19/2019; 03/02/2020; 03/02/2020
• Supplement Dates FDA Received: 11/11/2019; 03/10/2020; 03/31/2020
• Date Device Manufactured: 04/30/2019
• 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