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

Catalog Number	NCEUP3015X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: device was returned within the guide catheter and also with guidewire.The distal shaft was damaged with kinks evident on visual inspection, at 2.5 ¿ 4.5cm and 5.5cm distal to the guidewire entry port.Numerous kinks were evident to the hypotube and transition tubing.The balloon returned was partially inflated with traces of blood residue present inside the balloon.The distal portion of balloon was pulled proximally inside the proximal end of balloon.Deflation testing could not be performed due to condition of balloon.Proximal balloon bond was stretched and slightly bunched.A 0.015 inch mandrel would not load through the inner lumen, most likely due to deformation of the inner lumen.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use an nc euphora rx balloon catheter to treat a lesion located in the left anterior descending (lad).The target lesion was reported not to be tortuous or calcified.No damage noted to packaging, i.E.Shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray.No difficulties noted when removing the protective sheath/packaging stylette.The device was inspected with no issues.Negative prep was performed.The lesion was pre-dilated.The balloon was being used to post dilate a stent.The balloon did not pass through a previously-deployed stent, no resistance was encountered when advancing the device and no excessive force used during delivery.Originally, the product did not inflate.It was reported that the balloon would not deflate after first inflation, while in the patient.The device was not moved or repositioned prior to the deflation difficulties.Md intervened by pulling negative with a syringe and balloon came down enough to be removed.Patient status is fine.

• Brand Name: NC EUPHORA RX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 6776247
• Report Number: 9612164-2017-01020
• Device Sequence Number: 19217039
• Product Code: LOX
• UDI-Device Identifier: 00643169395855
• UDI-Public: 00643169395855
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2019
• Device Catalogue Number: NCEUP3015X
• Device Lot Number: 212676611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention