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

Model Number	ADM05012013P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
While using "in.Pact" drug eluting balloon (size 5 x 100) at nominal pressure, which is 8 atmospheres, the balloon ruptured, at which time the balloon catheter was removed from patient with no adverse effects.

• Brand Name: IN.PACT¿ ADMIRAL¿
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 3850 brickway blvd; santa rosa CA 95403
• MDR Report Key: 7053136
• Report Number: 7053136
• Device Sequence Number: 13780693
• Product Code: ONU
• UDI-Device Identifier: 00643169383630
• UDI-Public: (01)00643169383630(17)180809(10)0008152261
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2017
• Report Date (Section F): 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/09/2018
• Device Model Number: ADM05012013P
• Device Lot Number: 0008152261
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2017
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/17/2017