MAUDE Adverse Event Report: MEDTRONIC, INC. IN.PACT ADMIRAL; DRUG-ELUTING PERIPHERAL TRANSLUMINAL

Model Number ADM05004013P

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2018

Event Type  malfunction  

Event Description

The vascular surgeon was going to insert a balloon catheter and the balloon popped before reaching the patient.

• Brand Name: IN.PACT ADMIRAL
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3850 brickway blvd; santa rosa CA 95403
• MDR Report Key: 7933466
• MDR Text Key: 122641902
• Report Number: 7933466
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADM05004013P
• Device Catalogue Number: ADM05004013P
• Device Lot Number: 0008863385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Weight: 106