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

Catalog Number ADM06008013P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 10/24/2014

Event Type  Injury  

Event Description

During index procedure, two in.Pact admiral paclitaxel eluting pta balloon catheters were used to treat the right sfa.It is reported that approximately 3 days post index procedure, the patient experienced urticaria body trunk.Investigator assessed the event is not related to the study device, possibly related to the study procedure and remotely related to paclitaxel.It is reported that the event is resolved.

Manufacturer Narrative

Evaluation results: inherent risk of procedure ¿ (reaction).Evaluation conclusions: inherent risk of procedure ¿ (reaction).(b)(4).

Manufacturer Narrative

Cec adjudicated that the event was related to the device, procedure and paclitaxel.

• 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: 4574632
• MDR Text Key: 15911353
• Report Number: 3004066202-2015-00103
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2015
• Device Catalogue Number: ADM06008013P
• Device Lot Number: 2E021675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 03/06/2015
• Date Device Manufactured: 06/06/2013
• 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: 00070 YR
• Patient Weight: 57