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

Catalog Number PCF050200090

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528)

Patient Problems Thrombus (2101); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician was attempting to use a pacific xtreme balloon to treat multiple moderately calcified left sfa lesions (stenosis 95%).The artery was 6mm in diameter and non-tortuous.The device was removed from its packaging and inspected with no issues noted.The device was prepped as per the ifu.The procedure used a non-medtronic guidewire, 5 fr sheath and no embolic protection was used.The lesion was not pre-dilated.There was no resistance advancing the device and no excessive force was used.The device did not pass through a previously deployed stent.The device was first used for one inflation in the popliteal lesion with no issues.During inflation in the sfa at 10 atm, a circumferential balloon burst occurred.The physician recaptured the balloon and positioned a non-medtronic stent to jail the remaining balloon piece to the vessel wall.The doctor reported that the procedure to recapture the balloon and to position a stent was difficult and required a long time.It was reported that the piece detached from the pacific xtreme pta balloon was inside the vessel for a long time causing thrombus formation in the vessel.It is further reported that the thrombus embolised.It was not possible to administer an adequate heparin dose for the patient age and general condition.The leg of the patient was severely compromised before the intervention (signs of ulcers) and the situation seemed to be worse the end, probably caused by distal embolization.

Manufacturer Narrative

Evaluation summary: the device was not returned for evaluation.An image was provided showing the device in vitro after the procedure.The balloon was broken and a part of it was not present.The image confirmed the event reported from the field (burst with balloon detachment).A cd with angio images was provided.The cd showed the procedure: guidewire tracking through the lesion, balloon insertion, balloon inflation, vessel flow observation after the burst (loss of vascularization), multiple attempts to insert another guidewire into the vessel obstructed by the balloon, stent application and multiple stent post dilatation.Moreover vessel bleeding occurred distally to the stent and further balloon inflation was performed and successfully compressed the vessel.If information is provided in the future, a supplemental report will be issued.

• 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,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7323795
• MDR Text Key: 101886992
• Report Number: 9612164-2018-00480
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K103464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2020
• Device Catalogue Number: PCF050200090
• Device Lot Number: 214065379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2018
• Date Device Manufactured: 09/21/2017
• 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
• Patient Age: 84 YR