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

Catalog Number	EUP2012X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
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 used to treat a moderately tortuous, non calcified lesion exhibiting 95% stenosis in the mid diagonal branch.The device was not inspected.Negative prep was performed with no issues.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.The lesion was pre dilated using the 2.0 x 12 euphora balloon in the proximal diagonal.It was reported that the balloon burst at 12atm during the first inflation in the proximal diagonal resulting in a localized dissection in the proximal and mid vessel.An attempt was made to pass a 2.0 x 12mm resolute drug eluting stent but this was unsuccessful.An non medtronic 2.0 x 8mm balloon was successfully passed into the mid diagonal and successfully deployed at 8 atm.A 2.0 x 8mm resolute drug eluting stent was deployed into the proximal diagonal at 12 atm which successfully resolved the localized dissection.
Additional Manufacturer Narrative
Product analysis summary: a kink was evident on the hypotube.The balloon folds were expanded.Blood was visible in the balloon and inflation lumen.There was no damage evident to the proximal balloon bond.It was not possible to inflate the balloon.The device was placed in the waterbath to disperse the blood and aid inflation.Upon removal, the balloon was inflated with blood indicating a leak on the inner member or a burst.Damage was evident to the proximal balloon bond post inflation.It was not possible to deflate the balloon due to the damaged balloon bond.The balloon maintained pressure.Upon visual inspection of the balloon a burst site evident on the distal section of the balloon working length.Coagulated blood prevented the liquid exiting the burst site.The material was protruding outwards at the burst site.The outer shaft and balloon material were cut away to expose the inner member, to determine if there was a puncture site.Upon visual inspection there was no puncture site on the inner member.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.
Additional Manufacturer Narrative
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: 8910577
• Report Number: 9612164-2019-03485
• Device Sequence Number: 18903605
• Product Code: LOX
• UDI-Device Identifier: 00643169559882
• UDI-Public: 00643169559882
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/22/2019

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: 04/16/2021
• Device Catalogue Number: EUP2012X
• Device Lot Number: 217535675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 10/18/2019; 11/20/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 11/13/2019; 11/22/2019
• 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