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

Catalog Number PCU060200130

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana b.c,mx 2570 ; MX 2570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8159542
• MDR Text Key: 130178048
• Report Number: 9612164-2018-03604
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08033477058245
• UDI-Public: 08033477058245
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2021
• Device Catalogue Number: PCU060200130
• Device Lot Number: 216381328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2018
• Date Device Manufactured: 10/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention