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

Catalog Number	EUP3020X
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 one euphoria balloon catheter.The target lesion was located in the mid right coronary artery (rca).Abnormalities in relation to anatomy were noted, this was a chronic total occlusion(cto) procedure.No damage was noted to the device packaging and no issues reported when removing the device from the hoop/tray.The device was inspected and no issues were noted.It was reported that during initial insertion, the balloon ruptured and separated in the guide catheter.The patient was treated with a replacement medtronic balloon and no patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the device returned with a detachment on the hypotube approx.67cm distal to the strain relief.The remaining detached distal section of the device was lodged inside the guide catheter.A 0.035 inch mandrel was loaded through the guide catheter to remove the detached distal section of the device from the guide catheter.Kinks were evident along the hypotube both proximal and distal to the detachment site.The hypotube material was oval and uneven on both sides of the detachment site.The balloon folds were partially opened.There was slight deformation to the distal tip.A tuohy was attached to the hypotube of the detached distal portion of the device, in order to perform inflation testing.Negative prep was performed with no issues noted.The device was successfully inflated to 8atm with no issues noted, and maintained pressure.

• Brand Name: 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: 6390676
• Report Number: 9612164-2017-00252
• Device Sequence Number: 18846558
• Product Code: LOX
• UDI-Device Identifier: 00643169560161
• UDI-Public: 00643169560161
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143480
• 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,Followup
• Report Date (Section B): 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2018
• Device Catalogue Number: EUP3020X
• Device Lot Number: 212342584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 05/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1