MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME US; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	ADM070040080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician intended to use the admiral xtreme pta to treat the right iliac artery.It was reported the balloon was advanced to the lesion, and inflated across the right iliac lesion at 8 atmospheres for 60 seconds.During the second inflation after 3 minutes the balloon ruptured at nominal pressure.The balloon was removed over a wire, it was observed after removal that a fragment of the balloon was caught at the sheath.The physician pulled the sheath slightly back and with a blade cut down and with hemostats retrieved the fragmented balloon piece.The sheath was advanced back and held pressure.The site continued to bleed the physician upsized the sheath from a 5f,6f,7f,8f to a 9f sheath and applied pressure.The sight stopped bleeding with no further issues reported.

• Brand Name: ADMIRAL XTREME US
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 6926171
• Report Number: 9612164-2017-01419
• Device Sequence Number: 1444374
• Product Code: LIT
• UDI-Device Identifier: 08033477058078
• UDI-Public: 08033477058078
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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: 08/31/2019
• Device Model Number: ADM070040080
• Device Lot Number: 211990358
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 10/07/2017
• 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: 57 YR