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

Catalog Number	EUP2510X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A euphora rx ptca balloon catheter was attempted to be used to treat a mildy calcified, moderately tortuous lesion exhibiting 99% stenosis in the mid proximal obtuse marginal (om).The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that a balloon rupture occurred during balloon inflation.The balloon was firstly inflated to 10atm for 10 seconds, then to 12 atm for 9 seconds and it was reported that on the 3rd inflation at 8 atm the balloon lost pressure at 6 seconds.The patient is alive with no injury.
Additional Manufacturer Narrative
The original intended procedure was cardiac catheterization with selective coronary angiogram of the left and right coronary arteries, balloon angioplasty and stenting of the circumflex.The balloon was first inflated at 6 atm with no problem, then it was inflated to 7 atm.It was reported that on the 3rd inflation at 8 atm the balloon lost pressure at 6 seconds.It was reported that there was a leak of dye from the balloon indicating a rupture.The balloon was deflated, and the catheter was removed.A second catheter was required to complete the procedure.The balloon was inspected balloon and it was determined that no part of the balloon remained in the patient.Physical inspection of balloon did not reveal any missing parts.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the device returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, liquid was observed exiting the balloon proximal cone.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a longitudinal tear from the proximal cone to the mid-section of the balloon.The balloon material was uneven at the tear site.There was no lead in scratches evident proximal or distal to the tear site.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.

• 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: 8797532
• Report Number: 9612164-2019-02903
• Device Sequence Number: 2541020
• Product Code: LOX
• UDI-Device Identifier: 00643169560000
• UDI-Public: 00643169560000
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 10/09/2019

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: 03/21/2021
• Device Catalogue Number: EUP2510X
• Device Lot Number: 217347818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 07/22/2019; 09/13/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/19/2019; 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 98