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

Catalog Number ADM05012013P

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

Patient Problem Reaction (2414)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During index procedure the physician used two in.Pact admiral paclitaxel-eluting pta balloon catheters to treat a lesion located in the mid to prox sfa of the left leg.It is reported that the patient suffered a drug hypersensitivity reaction (fever) on the same day as the index procedure.The patient was treated with medication.The investigator assessed that the event was not related to the study device, procedure or drug.The clinical events committee assessed that the event was not related to the study device, but was related to the study procedure and drug.The event was resolved.

Manufacturer Narrative

Cec adjudicated the fever of unknown origin as a non-event.

Manufacturer Narrative

Cec adjudicated the fever of unknown origin 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 ; CH
• Manufacturer (Section G): INVATEC TECHNOLOGY CENTER GMBH; hungerbuelstrasse 12; frauenfeld
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5525647
• MDR Text Key: 41132636
• Report Number: 3004066202-2016-00089
• 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
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• 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: ADM05012013P
• Device Lot Number: 2E021451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2016
• 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 Age: 00066 YR
• Patient Weight: 54