MAUDE Adverse Event Report: INVATEC SPA REEF HP; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number REU070080082

Device Problems Burst Container or Vessel (1074); Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/06/2017

Event Type  Injury  

Event Description

The physician use the product in a avf case, the balloon was ruptured and the shaft was broken after inflating the balloon to 18 bar, not exceeding the rbp.The physician then performed open procedure to take out the product.The patient was fine after the operation.

Manufacturer Narrative

Device evaluation: the device was returned inserted in a plastic pouch.Traces of blood was detected on the device and introducer sheath.The reef device was returned with the guide wire 0.035" blocked and the balloon broken into the introducer sheath.The balloon was found broken radially so it was not possible to remove it through the is.The guide wire tube between the markers band was cut and is removed.The guide wire tube was stretched over the guide wire under the balloon.The balloon was radially broken at 40 mm from the tip.The is was longitudinally cut due to the attempt to remove the balloon.Image review: from the analysis of angiographic images provided it is clearly visible the lesion to treat (avf case).Reef balloon was inflated till 18 bar but burst (under rbp).No additional information could be found based on the information provided.From the information provided by the field it is reasonable to suppose that the failure was lesion morphology related.Lesion such as avf are usually very challenging.They usually show very tight curvature and they could be very hard to be dilated.

• Brand Name: REEF HP
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer (Section G): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6379796
• MDR Text Key: 69097181
• Report Number: 3004066202-2017-00028
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K092361
• 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: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2019
• Device Catalogue Number: REU070080082
• Device Lot Number: 1H010622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2016
• 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