MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT AV ACCESS; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number AVC10004008P

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

Patient Problems Stenosis (2263); Injury (2348)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During index procedure, two inpact av access paclitaxel eluting balloon catheters were used to treat the left venous cephalic arch.Approximately 13 months post procedure, patient suffered stenosis in the cephalic arch which was treated with medication and revascularization.A non-medtronic pta balloon was used during revascularization to treat the target lesion cephalic arch.Investigator and sponsor assessed event is not related to device, procedure or paclitaxel.

• Brand Name: IN.PACT AV ACCESS
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10118166
• MDR Text Key: 193929181
• Report Number: 9612164-2020-02098
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2020

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: 11/02/2018
• Device Catalogue Number: AVC10004008P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/04/2020
• Date Device Manufactured: 02/02/2018
• 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: 57 YR