MAUDE Adverse Event Report: TRIREME MEDICAL CHOCOLATE PTCA BALLOON CATHETER 3.5X20MM

Catalog Number CH14-140-3520-RX

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/17/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned by the user facility.

Event Description

Physician was performing angioplasty in patient's right posterial tibial artery.After 8 inflations and deflations along posterial tibial artery, physician attempted to withdraw the chocolate balloon through a 5fr terumo destination sheath that was from a contralateral approach.Balloon was over a 014 command wire.The balloon was withdrawn about halfway into sheath when it got hung-up on the edge of the sheath and couldn't be totally withdrawn through sheath.The sheath and balloon had to be withdrawn from patient as a single unit which was successful.Before doing this the physician tried to capture the entire system with 7fr cook sheath but was unsuccessful.Physician commented that most likely cause was the nitinol cage around the balloon got caught on distal edge of the sheath because of high number of inflations and deflations and may not have been deflated when tried to withdraw the balloon.

• Brand Name: CHOCOLATE PTCA BALLOON CATHETER 3.5X20MM
• Type of Device: PTCA BALLOON CATHETER
• Manufacturer (Section D): TRIREME MEDICAL; 7060 koll center parkway; suite # 300; pleasanton CA 94566
• Manufacturer (Section G): TRIREME MEDICAL; 7060 koll center parkway; suite 300; pleasanton CA 94566
• Manufacturer Contact: shiva ardakani ; 7060 koll center parkway; suite # 300; pleasanton, CA 94566 ; 9259311300
• MDR Report Key: 5943409
• MDR Text Key: 54459037
• Report Number: 3008089360-2016-00002
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: CH14-140-3520-RX
• Device Lot Number: F160105100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR