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

Catalog Number NCEUP3508X

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the distal shaft material was torn. Stretching was evident to the inner member. The support wire was exposed. Deformation was evident to the guidewire entry port and the material was protruding outwards. Damage was evident to the inner member along the entire length of the distal shaft, the material appeared to be protruding outwards. The damage appeared to spiral along the inner member. Slight deformation was evident to the distal tip. No other damage was evident to the remainder of the device. An a device image was provided. The image is of the distal section of a device. On magnification of the image, it is evident the support wire is exposed and the distal shaft material is torn. If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure a nc euphora ptca balloon catheter was used to post dilate a resolute onyx stent which was implanted to treat a moderately tortuous, non calcified lesion located in the mid left anterior descending artery (lad). There was no damage noted to the packaging. No damage was noted prior to use in the patient. Negative prep was not performed. The lesion was not pre-dilated. The device passed through a previously deployed stent. Resistance was not encountered when advancing the device and excessive force was not used during delivery. It was reported that deformation of the catheter occurred, stretching was noted at the catheter. The device was removed. The patient is reported to be alive with no injury.

• 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: 8644090
• MDR Text Key: 146233673
• Report Number: 9612164-2019-01971
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/27/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/24/2021
• Device Catalogue Number: NCEUP3508X
• Device Lot Number: 217198767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial