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

Catalog Number	PCU060200130
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/06/2018
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
The physician intended to use the pacific xtreme with a 6f non-medtronic sheath a 014 non-medtronic guidewire and a non-medtronic i nflation device to treat moderate stenosis in the popliteal artery.The ifu was followed and the device prepped with no issues identified.The artery diameter was 6mm and moderately calcified lesion was 80mm.The device did pass through a previously deployed stent but no resistance or excessive force was used.There was no interaction between the balloon and the stent.It was reported during treatment of an in-stent restenosis the balloon fractured and detached during inflation in the patient's popliteal artery.The device was removed from the patient without issue leaving the detached segment of balloon in the patient.A protégé everflex was used to cage the balloon.

• 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 b.c,mx 2570 ; MX 2570
• MDR Report Key: 8159542
• Report Number: 9612164-2018-03604
• Device Sequence Number: 2126478
• Product Code: LIT
• UDI-Device Identifier: 08033477058245
• UDI-Public: 08033477058245
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/13/2018

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: 10/10/2021
• Device Catalogue Number: PCU060200130
• Device Lot Number: 216381328
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/13/2018
• 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