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

Catalog Number	NCEUP3027X
Medical Device Problem Codes	Burst Container or Vessel (1074); Deflation Problem (1149)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/02/2018
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
An nc euphora balloon catheter was being used to post dilate a stent that was implanted in a mildly tortuous, mildly calcified lesion with 95% stenosis in the distal circumflex.There was no abnormality in relation to anatomy.There was no damage noted to the device packaging.There were no issues removing the device from the hoop.No issues noted when removing the protective sheath or removing the stylette.The device was inspected with no issues.Negative prep was performed with no issues.It is indicated that the balloon may not have been flushed through the hoop or placed in a bowl of saline prior to use.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.Sixty saline/40 contrast was used.No issues were noted during inflation.It is reported that the balloon would not deflate at the lesion site after first inflation.The device was not moved or repositioned prior to the deflation difficulties.First the physician tried to pull negative pressure with a larger syringe without success.Then the physician re-inflated the balloon and pulled negative pressure but only one third of the balloon deflated.Then the physician delivered a non-medtronic catheter over a non-medtronic wire proximal to the balloon and turned the wire backwards through the non-medtronic catheter in an attempt to pop the balloon which was unsuccessful.The physician then dilated the balloon to extreme high pressure, 30 atm and ruptured the balloon which then deflated.The balloon was removed from the vessel successfully.No patient injury is reported.The procedure was completed with a non-medtronic balloon.
Additional Manufacturer Narrative
Evaluation summary: the balloon returned with contrast visible in the balloon and inflation lumen.The device was placed in a water bath overnight to disperse contrast.It was visible that a portion of the distal shaft had been inflated proximal to the balloon bond.The balloon passed negative prep.On pressurisation of the device, the balloon inflated partially and a portion of the distal shaft inflated.The balloon failed to maintain pressure, due to the backflow of fluid into the proximal portion of the distal shaft.The analyst did not further inflate.Stretching of the distal shaft was visible to the balloon bond.The distal tip was flared.Inflation/deflation time could not be measured as the balloon could not inflate to nominal pressure.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: 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: 7547761
• Report Number: 9612164-2018-01247
• Device Sequence Number: 1305299
• Product Code: LOX
• UDI-Device Identifier: 00643169395831
• UDI-Public: 00643169395831
• 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): 10/05/2018

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: 11/10/2019
• Device Catalogue Number: NCEUP3027X
• Device Lot Number: 214370896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 06/20/2018; 08/08/2018
• Initial Report FDA Received Date: 05/28/2018
• Supplement Report FDA Received Date: 07/17/2018; 10/04/2018
• 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