MAUDE Adverse Event Report: INVATEC TECHNOLOGY CENTER GMBH IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number SBI07004008P

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a physician used an inpact admiral drug eluting balloon approximately 23 days post expiry.Procedure was completed with no complications reported.No patient injury or clinical sequelae were reported for this event.

Manufacturer Narrative

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

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): INVATEC TECHNOLOGY CENTER GMBH; hungerbuelstrasse 12; frauenfeld 8500 ; CH 8500
• Manufacturer (Section G): INVATEC TECHNOLOGY CENTER GMBH; hungerbuelstrasse 12; frauenfeld 8500 ; CH 8500
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5849254
• MDR Text Key: 51228289
• Report Number: 3004066202-2016-00217
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P140010
• 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: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: SBI07004008P
• Device Lot Number: 2F021935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 08/05/2016
• Supplement Dates Manufacturer Received: 07/07/2016
• Supplement Dates FDA Received: 09/24/2017
• Date Device Manufactured: 06/01/2014
• 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 Age: 71 YR