MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess the performance of medtronic¿s pacific plus pta balloon catheter. Survey results received for an interventional cardiologist with 5 years¿ experience. The respondent has been using medtronic¿s pacific plus pta balloon catheter since (b)(6) 2019. Overall, the respondent has used medtronic¿s pacific plus pta balloon catheter in a total of 35 procedures since beginning to use the system. Of these procedures, the devices were used for dilatation of stenoses in patients with obstructive disease in iliac arteries (10), femoral arteries (10), iliofemoral arteries (5), popliteal arteries (5), and infrapopliteal arteries (5). All of these procedures were carried out in the past 12 months. The respondent has not used medtronic's pacific plus pta balloon catheter in any other anatomical locations other than those described above. The respondent reports complications of thrombosis associated specifically with puncture. The complications of thrombosis were deemed as being related to the device.

• Brand Name: PACIFIC PLUS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 10688661
• MDR Text Key: 216395767
• Report Number: 9612164-2020-03945
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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
• Report Date: 10/16/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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: 10/09/2020
• 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: Initial