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

Catalog Number EUP2015X

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the procedure an attempt was made to use one sc euphora rx ptca balloon catheter to treat a lesion.The device was inspected with no issues noted.The lesion was not 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.It was reported that balloon deflation difficulties occurred and the balloon would not deflate at the lesion site.The balloon was inflated above the rbp until it burst.The patient was unharmed.

Manufacturer Narrative

Product analysis summary: a kink was evident on the hypotube 24cm distal to the strain relief.The device returned deflated.A portion of the balloon bond and the material immediately proximal to the proximal balloon bond appeared to have inflated.Stretching was evident to the balloon bond.The device was inflated to nominal pressure of 8 atm.The balloon, a section of the proximal balloon bond and the inflation lumen immediately proximal to the proximal balloon bond appeared to have inflated.The balloon appeared to be curved.An attempt was made to perform deflation testing however the balloon burst, therefore deflation testing could not be completed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Add info: no difficulties were noted when removing the protective sheath and stylette.No difficulties were noted during inflation of the device.The device was not moved or repositioned prior to the deflation difficulties.The deflation difficulties occurred after first inflation.50/50 concentration of contrast / saline was used.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: 8259946
• MDR Text Key: 133462835
• Report Number: 9612164-2019-00228
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2020
• Device Catalogue Number: EUP2015X
• Device Lot Number: 216324969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2018
• 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