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

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

Patient Problem Vasoconstriction (2126)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

Event date: approximate event date.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.

Event Description

During the use with inpact pacific, inpact admiral and inpact amphiprion drug eluting balloons, it was reported that a physician indicated he has observed slow / low flow in spite of using vasorelaxants (e.G., nitro, gb23a/amixibab).The situation appeared to be temporary and resolved itself within a reasonable time without re-intervention.The physician reported that it could be related to clearance through the microvasculature and that it was not the vessel itself that spasms or narrows, but an increased impedance on downstream clearance caused either by multiple lateral plaque shifts (exacerbated by the use of multiple short balloons) or by matrix particles.No patient safety concerns were expressed.This was reported as an observation by the physician.The physician reported the observation rate was very low at ~5%.From the perspective of safety, the physician indicated that the phenomenon rapidly and easily resolved in 5m with the use of abciximab, so he felt he had an adequate resolution when this infrequent condition was observed.

• 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): INVATEC TECHNOLOGY CENTER GMBH; hungerbuelstrasse 12; frauenfeld 8500 ; CH 8500
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5650616
• MDR Text Key: 45038885
• Report Number: 3004066202-2016-00155
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 06/16/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2016
• 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