MAUDE Adverse Event Report: TRIREME MEDICAL, INC. CHOCOLATE PTA BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Lot Number F140725007

Device Problems Difficult to Remove (1528); Component Missing (2306)

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

Event Date 04/28/2015

Event Type  Injury  

Event Description

During a pta of a right leg a chocolate balloon was inflated.After inflation the balloon was removed and upon inspection, the nitinol wire that is usually on the balloon was not present.Upon further angiography of the right leg the nitinol wire was located in the stent and we could not retrieve it.

• Brand Name: CHOCOLATE PTA BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): TRIREME MEDICAL, INC.; 7060 koll center parkway suite; pleasanton CA 94566
• MDR Report Key: 4846832
• MDR Text Key: 5937243
• Report Number: 4846832
• Device Sequence Number: 1
• Product Code: LIT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: F140725007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 97