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	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a pacific xtreme during treatment of an unknown lesion in the patient¿s proximal superficial femoral artery (sfa).Ifu was followed.Device was prepped without issue.An everest inflation device was used for balloon inflation.It is reported that a balloon burst occurred at 6atm.All balloon fragments retrieved.Another pta balloon of same size was used to complete the procedure.No injury reported.
Additional Manufacturer Narrative
Additional information: the balloon was removed intact.No removal difficulties experienced.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACIFIC XTREME
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8878271
• Report Number: 9612164-2019-03311
• Device Sequence Number: 16676346
• Product Code: LIT
• UDI-Device Identifier: 08033477075938
• UDI-Public: 08033477075938
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2022
• Device Catalogue Number: PCU070200130
• Device Lot Number: 217452007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR