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

Catalog Number	PCU070200130
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician employed the use of a pacific xtreme pta balloon catheter with a non-mdt inflation device for the treatment of a 100% stenosed fibrous/plaque lesion in the mid-proximal superficial femoral artery (sfa).Lesion was slightly calcified.Vessel slightly tortuous.Ifu was followed.Device prepped without issue.It was reported that a circumferential/radial balloon burst occurred at an inflation pressure of 8-9atms.One inflation was applied to the balloon previous to burst.The device did pass through a previously deployed stent, but no resistance was encountered / no excessive force required.A part of the balloon ruptured off the catheter and became lodged within the mid-sfa.A 10mm snare device was used to retrieve the ruptured balloon (all fragments retrieved).No patient injury was reported.

• Brand Name: PACIFIC XTREME
• 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: 7127035
• Report Number: 9612164-2017-01998
• Device Sequence Number: 1260569
• Product Code: LIT
• UDI-Device Identifier: 08033477058320
• UDI-Public: 08033477058320
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103464
• 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
• Report Date (Section B): 12/18/2017

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: 04/30/2020
• Device Catalogue Number: PCU070200130
• Device Lot Number: 213333749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/18/2017
• 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