MAUDE Adverse Event Report: INVATEC SPA PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number UNK-CV-GWY-PCP

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

Patient Problems Occlusion (1984); Thrombus (2101)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

The cec has adjudicated that the event is related to the device but not the procedure or paclitaxel. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

It was informed that the event was also treated with rotarex. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During a revascularization of the target lesion an in. Pact paclitaxel eluting balloon catheter was used. During another revascularization of the target lesion two pacific plus pta balloons were used. Also, during another revascularization of the target lesion an in. Pact pacific paclitaxel eluting balloon catheter was used. Approximately 16 months post first revascularization, 10 months post second revascularization and 7 months post third revascularization, patient suffered acute thrombotic occlusion of the right distal sfa. Following day, an amphiprion deep pta balloon was used during revascularization. Patient recovered. Investigator assessed the event is not related to the study device, procedure or paclitaxel.

• Brand Name: PACIFIC PLUS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer (Section G): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7099336
• MDR Text Key: 109697597
• Report Number: 3004066202-2017-00121
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK-CV-GWY-PCP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 12/08/2017 Patient Sequence Number: 1