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

Catalog Number EUP2515X

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a procedure a euphora rx ptca balloon catheter was intended to be used to treat a lesion.There was no damage noted to the packaging.The device was inspected with no issues noted.It was reported that difficulties were encountered removing the stylette and protective cover which resulted in a tear in the scrub personnel's glove and damage to the balloon.It was reported that the balloon was not functional after removal of stylette and protective cover.

Manufacturer Narrative

Product analysis summary: the sheath and stylette did not return for analysis.No deformation was evident to the distal tip.Contrast was visible in the balloon.The balloon was deflated, the balloon folds were expanded.There was no damage evident to the balloon.The proximal balloon bond was necked and stretched.It was not possible to perform inflation or deflation testing due to the condition of the proximal balloon bond.There was no other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the device was used in the patient.The scrub replaced the glove before they continued on with the procedure.The balloon was inserted into the lesion and inflated as normal.However the balloon was slow to inflate.At this point it was known that the device was not functioning properly and negative pressure was performed.The balloon would not deflate.Eventually enough contrast/flush solution was removed to carefully remove the device from the lad lesion.No damage to the vessel was angiographically evident.The target lesion was then stented and post dilated with a good result.The patient was not harmed and is doing fine.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: 8915473
• MDR Text Key: 155070516
• Report Number: 9612164-2019-03509
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169560024
• UDI-Public: 00643169560024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2021
• Device Catalogue Number: EUP2515X
• Device Lot Number: 217850427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2019
• Date Device Manufactured: 06/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 9612164-09-12-2019-001-R
• Patient Sequence Number: 1