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

Catalog Number	NCEUP32520X
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/01/2019
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
During a procedure an nc euphora rx ptca balloon catheter was used to treat the mid rca.It is reported that the balloon ruptured when inflated to dilate the mid rca.Upon extracting the balloon it was noted that part of the balloon remained in the rca.The balloon fragment was excluded by realigning the vessel with an overlapping stent.There is no further patient injury reported.
Additional Manufacturer Narrative
Product analysis summary: a kink was evident on the hypotube, tactile testing confirmed kink.The inner member, a section of the balloon and the distal tip were detached and did not return for analysis.The balloon appeared to have burst radially.There was approx.1.5mm of balloon material remaining on the device.The balloon material was jagged and uneven at the burst site.The inner member material appeared clean at the detachment site.There was no damage evident to the remainder of the device.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: 8554104
• Report Number: 9612164-2019-01480
• Device Sequence Number: 16686519
• Product Code: LOX
• UDI-Device Identifier: 00643169395787
• UDI-Public: 00643169395787
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: 12/14/2020
• Device Catalogue Number: NCEUP32520X
• Device Lot Number: 216799569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 09/25/2019
• 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
• Patient Age: 72 YR