MAUDE Adverse Event Report: MEDTRONIC MEXICO AMPHIRION DEEP OTW; CATHETER, PERCUTANEOUS

Catalog Number AMD335210152

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a physician was attempting to use an amphiprion deep otw balloon catheter to treat a lesion in a patient.First inflation was carried out in the distal sfa, second inflation in btk, third inflation in distal sfa and then the balloon was ruptured.While removing the ruptured balloon, catheter was broken (cut).The broken part of the balloon remained in the body and then it was reported that the broken part of the balloon was removed with an extra open surgery.No other clinical sequelae reported for this event.

Manufacturer Narrative

Additional information received reported that the vessel is straight; lesion is severely calcified and totally occluded.The balloon was ruptured in sfa artery (a little bit proximal from the stent) and the balloon was broken in iliac artery.The patient¿s iliac artery was heavily calcified.The balloon seems to be stuck and broken in heavily calcified iliac artery.

Manufacturer Narrative

Device evaluation: the balloon was removed from the hoop and visual inspected: the balloon part was missing.The catheter was broken at proximal balloon welding (127 cm from the hub) and the gw lumen was broken at 121 cm from the hub.A flushing of the gw lumen was performed by connecting a syringe filled by water to the hub, the water goes out from the guidewire tube normally.A 0.014¿ guidewire was inserted in the hub of the catheter however it failed due to stretching of the guide wire lumen.

• Brand Name: AMPHIRION DEEP OTW
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana, b.c.,mx
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5313257
• MDR Text Key: 33947442
• Report Number: 9612164-2015-01903
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K052791
• 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,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: AMD335210152
• Device Lot Number: 208795401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2014
• 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: 00075 YR