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

Catalog Number	PCU050250130
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Physician was attempting to treat a moderately calcified/fibrous lesion exhibiting little tortuosity using three pacific xtreme balloon catheters.The lesion was totally occluded (cto 100% stenosis) and vessel was little tortuous.It was reported that during balloon inflation, physician experienced inflation difficulties when balloon twist was noted on the three devices.A smaller more focal balloon was used to complete the procedure.There was no injury to patient.
Additional Manufacturer Narrative
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: 6222026
• Report Number: 9612164-2017-00006
• Device Sequence Number: 18934494
• Product Code: LIT
• UDI-Device Identifier: 08033477035536
• UDI-Public: 08033477035536
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/09/2016

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: 08/31/2019
• Device Catalogue Number: PCU050250130
• Device Lot Number: 212019878
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2016
• Supplement Date Received by Manufacturer: 12/09/2016
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR