MAUDE Adverse Event Report: INVATEC SPA AMPHIRION PLUS; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number AHP020120152

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2013

Event Type  malfunction  

Event Description

It was reported that while attempting to treat a severe calcified lesion in btk vessel using an amphirion plus device, the physician noted the balloon ruptured during the first inflation at 6 atm immediate after starting inflation on the first inflation.Slight resistance was experienced when the device was delivered to the lesion.After the event, the device was withdrawn safely and the procedure was completed using other device.The device was prepared following the ifu and no abnormalities noted.No patient injury was reported for this event.Device return: during the technical investigation the returned sample was visually inspected.There is no evidence of dirt or clotted blood all along the device.Catheter hub, shaft tube and balloon portion (including also the device tip) do not show any damage.Balloon appears unfolded.A 0.014'' guide wire was inserted in the guide wire lumen without resistance.The balloon was inflated with water using a manometric syringe at 10atm but it could not hold the pressure and a pinhole was detected on the distal portion of the balloon.The balloon was inflated with air to detect the location of the pinhole.The pinhole was around 0.3mm long and located on the balloon distal neck not involved in the distal balloon welding with the guide wire tube (tip).

Manufacturer Narrative

Evaluation: results/conclusion: most likely procedural related.Patient lesion morphology, severely calcified lesion.(b)(4).

• Brand Name: AMPHIRION PLUS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 2503 0; 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: 3610985
• MDR Text Key: 4170383
• Report Number: 3004066202-2014-00016
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2015
• Device Catalogue Number: AHP020120152
• Device Lot Number: 1D028209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2012
• 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