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

Catalog Number	NCEUP32515X
Medical Device Problem Codes	Burst Container or Vessel (1074); Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Code Available (3191)
Date of Event	06/14/2018
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
The lesion was a non-tortuous, non-calcified cto in the lad, one 3.0x15 resolute onyx drug eluting stent was implanted with no difficulties reported.The lesion had been pre-dilated.An attempt was made to post dilate the stent with an nc euphora balloon.No damage had been noted to the nc euphora packaging.There were no issues noted when removing the balloon from the hoop/ tray.There were no issues removing the stylette.The device was inspected and prepped with no issues noted.No resistance was encountered when advancing the balloon, excessive force was not used.Inflation difficulties were experienced with the balloon, taking longer than expected to inflate (1 sec to get to 12 atms).The stent was post dilated and deflation difficulties were then encountered.The balloon was ruptured by taking the balloon to high atmosphere with the inflation device.On removal of the balloon catheter and guide wire, par t of the balloon had detached and remained in the left main.A snare was unsuccessful in retrieving the detached part of the balloon.Three procedure wires were introduced into the patient, torqued and were successful in capturing and removing the detached part of the balloon.Patient is stable, vitals are consistently stable.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: an inflation device was received with the complaint device.The device returned with a guidewire loaded through it.The device returned with a detachment of the distal shaft outer, 23.7cm distal to the guidewire entry port.The balloon and distal tip detached from the delivery system.The material at the detachment site was jagged and uneven on both sides of the detachment site.It was not possible to perform inflation or deflation testing due to detachment of material at the distal shaft outer.If information is provided in the future, a supplemental report will be issued.

• 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: 7668996
• Report Number: 9612164-2018-01655
• Device Sequence Number: 2771765
• Product Code: LOX
• UDI-Device Identifier: 00643169395794
• UDI-Public: 00643169395794
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup,Followup
• Report Date (Section B): 10/17/2018

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: 04/09/2020
• Device Catalogue Number: NCEUP32515X
• Device Lot Number: 215229369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/20/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/17/2018
• 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
• Patient Age: 62 YR