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

Catalog Number EUP27512X

Device Problems Difficult to Open or Remove Packaging Material (2922); Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: approximate date (month and year valid only).

Event Description

The physician intended to use a euphora balloon catheter.There was no damage noted to packaging.There were no issues when removing the device from the hoop.Negative prep was not performed.It is reported that the stylette was sticking on removal and that it pierced the health care professional's glove.Device was not used in patient.There is no patient injury.

Manufacturer Narrative

Evaluation summary: the stylette was present in the tip of the returned device.During analysis it was not possible to remove the stylette.No residue was visible on the stylette.Residue was visible in the inflation lumen.The balloon bond was stretched.Numerous kinks were evident on the hypotube and distal shaft.The balloon could not be inflated due to stretching at the balloon bond.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: 6803074
• MDR Text Key: 83116729
• Report Number: 9612164-2017-01131
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2019
• Device Catalogue Number: EUP27512X
• Device Lot Number: 212820596
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-3136-2017
• Patient Sequence Number: 1