MAUDE Adverse Event Report: MEDTRONIC, INC. EUPHORA¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number EUP3515X

Device Problems Material Fragmentation (1261); Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/07/2023

Event Type  malfunction  

Event Description

Patient came in for an outpatient heart catheterization.It was found that the patient needed percutaneous coronary intervention (pci) to the mid right coronary artery (rca).Guide catheter, guide wire, and balloon was inserted without difficulty.Upon inflation of balloon for his percutaneous transluminal coronary angioplasty (ptca), the balloon ruptured.There were retained balloon fragments in the coronary artery that were unable to be extracted/snared.The patient then needed to go to the or emergently to retrieve the balloon fragments.The patient had an emergent coronary artery bypass graft (cabg) x 1 (reverse saphenous vein graft (rsvg)-> rca).Manufacturer response for rapid exchange balloon dilatation catheter, euphora (per site reporter).Clinical representative will report it to medtronic.

• Brand Name: EUPHORA¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 3576 unocal place; santa rosa CA 95403
• MDR Report Key: 16395856
• MDR Text Key: 309744920
• Report Number: 16395856
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EUP3515X
• Device Catalogue Number: EUP3515X
• Device Lot Number: (17)231117(10)223334471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Race: White