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

Catalog Number REU060040082

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/14/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician intended to use a reef pta balloon to treat an intravenous fistula. There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop. The device was not prepped per ifu. The device was inflated with a non medtronic device. The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device to the fistula. It was reported that, during the procedure, when the balloon pressure was 20, the front of the balloon became disconnected. Upon applying further pressure, the balloon did not maintain inflation. When the balloon was removed, it was found that some of it had become detached and some remained in the patient vasculature. Post procedure, a surgical cut down was required to retrieve the detached portion of the balloon.

• 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: 8711350
• MDR Text Key: 148401626
• Report Number: 3004066202-2019-00027
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/06/2020
• Device Catalogue Number: REU060040082
• Device Lot Number: 1I002692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/19/2019 Patient Sequence Number: 1