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

Catalog Number SBI04012008P

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The physician used an in.Pact admiral paclitaxel eluting pta balloon catheter that was past its expiration date by approximately 10 days.No clinical sequelae reported.The device performed as intended and no medical intervention required due to its use beyond the expiration date.

• 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): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5273038
• MDR Text Key: 33366592
• Report Number: 3004066202-2015-00523
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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
• Report Date: 11/13/2015

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: 11/01/2015
• Device Catalogue Number: SBI04012008P
• Device Lot Number: 2D030058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/08/2015
• Date Device Manufactured: 11/01/2012
• 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
• Patient Weight: 61