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

Catalog Number ADM05008013P

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

Patient Problem Reaction (2414)

Event Date 10/24/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During index procedure, the physician used one in.Pact admiral paclitaxel-eluting pta balloon catheter to treat a lesion located in the sfa of the left leg.Device was successful.Approximately 2 days post index procedure, the patient had drug hypersensitivity/reaction which was treated with medication.Investigator assessed that the event was not related to the study device, but related to the procedure or paclitaxel.

Manufacturer Narrative

The cec adjudicated the event to be related to the drug but not related to the device or procedure.

Manufacturer Narrative

Patient had did not have a history of peripheral revascularization to the left common femoral as previously reported.

Manufacturer Narrative

The cec adjudicated the previously reported drug hypersensitivity/reaction to be not related to the device but related to the procedure and drug.Cec adjudicated this reported drug hypersensitivity/reaction as an event.

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.

• 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: 5491955
• MDR Text Key: 40048034
• Report Number: 3004066202-2016-00079
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/20/2016

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: 06/04/2015
• Device Catalogue Number: ADM05008013P
• Device Lot Number: 2E021449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 04/20/2016
• Supplement Dates FDA Received: 03/22/2016; 03/31/2016; 05/16/2016; 09/22/2017
• Date Device Manufactured: 06/04/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 00082 YR
• Patient Weight: 57