MAUDE Adverse Event Report: INVATEC SPA AMPHIRION DEEP RX; CATHETER, PERCUTANEOUS

Catalog Number AMD253210RX2

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Physician was attempting to treat a lesion in the posterior tibial artery (pta) and the anterior tibial artery (ata) using amphirion deep dilatation balloon catheter.After dilatation was performed several times on the posterior tibial artery and anterior tibial artery, the device could not perform further dilatation.Suspecting a kink on the shaft, the physician attempted deflating the device several times by pulling the balloon back, and deflated the balloon partially.In an attempt to retract the device, the lumen was stuck on the guidewire, and the device could not be pulled out completely from where it was, out of the sheath.When the physician tried to pull it by force, the balloon and the shaft were torn apart.Eventually, the device was removed after cutting the guidewire.There was no adverse effect on the patient.

Manufacturer Narrative

Device evaluation: the device was found broken close to the hypotube end.Traces of radio opaque solution was detected in the balloon.All the distal part of the outer shaft was missing.The balloon and the guide wire tube was returned.A portion of the guide wire was stuck on the guide wire tube.The balloon was removed and the guide wire tube was damaged all length long (accordion effect).

Manufacturer Narrative

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

• Brand Name: AMPHIRION DEEP RX
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5318141
• MDR Text Key: 34785572
• Report Number: 3004066202-2015-00533
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2018
• Device Catalogue Number: AMD253210RX2
• Device Lot Number: 1G015779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• 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