MAUDE Adverse Event Report: MEDTRONIC MEXICO SPRINTER OTW; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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

Patient Problems Unspecified Infection (1930); Myocardial Infarction (1969); Occlusion (1984); Stenosis (2263); Vascular Dissection (3160)

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 performance of the sprinter otw ptca balloon catheter survey results from an interventional cardiologist in practice 2 years.In the past 12 months the physician has used sprinter otw 200 times; sprinter otw (1.50 x 6 mm), sprinter otw (other intermediate size) and sprinter otw (4.00 x 30 mm) were used the following complications adverse events/effects were encountered using the sprinter otw product over the last 12 months: 1 mi, 1 total occlusion and 1 restenosis events were related to the procedure but not directly to sprinter otw.1 dissection and 1 infection events were directly related to sprinter otw.

• Brand Name: SPRINTER OTW
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• 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: 9321246
• MDR Text Key: 167019669
• Report Number: 9612164-2019-04747
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2019

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
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/14/2019
• 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