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

Catalog Number SBI05008008P

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

Patient Problem Fever (1858)

Event Date 04/14/2015

Event Type  Injury  

Event Description

During the index procedure, one in.Pact admiral paclitaxel-eluting pta balloon catheter was used to treat a lesion located in the left mid/distal sfa.The patient suffered from fervescence on the same day as the index procedure and was treated with medication.The investigator assessed that the event was possibly related to the study device, remotely related to the study procedure and possibly related to the paclitaxel.Outcome is resolved.

Manufacturer Narrative

Evaluation results: root cause unknown.Evaluation conclusions: root cause unknown.(b)(4).

• 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: 4738976
• MDR Text Key: 5884068
• Report Number: 3004066202-2015-00205
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Catalogue Number: SBI05008008P
• Device Lot Number: 2E027139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2015
• Date Device Manufactured: 08/01/2013
• 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: 00063 YR
• Patient Weight: 68