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

Catalog Number NCEUP3520X

Device Problems Deflation Problem (1149); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a procedure a nc euphora rx ptca balloon catheter was used to treat a non calcified, non tortuous distal right coronary artery.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that the balloon was inflated to 20atm during subsequent inflation and could not be deflated at the lesion site.The patient is alive with no injury.It is indicated from images that the balloon and catheter shaft are deformed.

Manufacturer Narrative

The procedure was not a complex pci case.A non-medtronic wire was used.No issues were noted during inflation.2 inflations were performed before deflation difficulties occurred.One at 12atm and one at 20atm.The physician tried to deflate again and then removed the balloon.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation summary: a kink was evident on the hypotube.The proximal balloon bond and the distal shaft immediately proximal to the balloon bond was torn.The proximal marker band was exposed.The material was jagged and uneven at the tear site.The distal section of the balloon was bunched around the tip.There was no damage evident to the distal tip.Deformation was evident to the exchange joint.Deformation was evident to the transition shaft.It was not possible to perform deflation testing due to the condition of the returned device.There was no other damage evident to the remainder of the device.Image review: images provided are the same images taken at different angles.The image are of a poba device.A section of the distal shaft appears to be torn.Blood is visible in the balloon and the torn section of the distal shaft.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: 8715375
• MDR Text Key: 148543092
• Report Number: 9612164-2019-02444
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: NCEUP3520X
• Device Lot Number: 214838994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 06/20/2019; 07/26/2019; 08/23/2019
• Supplement Dates FDA Received: 07/15/2019; 08/21/2019; 09/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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