MAUDE Adverse Event Report: TRIREME MEDICAL INC. CHOCOLATE PTA BALLOON CATHETER

Catalog Number CB14-135-40120CW

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/20/2018

Event Type  Injury  

Event Description

Chocolate pta balloon catheter was inserted into patient's sfa to balloon.After balloon was deflated it got hung up on the stent and the balloon broke off the shaft as it was being removed over the wire.The balloon was successfully retrieved and removed intact.

• Brand Name: CHOCOLATE PTA BALLOON CATHETER
• Type of Device: BALLOON CATHETER
• Manufacturer (Section D): TRIREME MEDICAL INC. ; pleasanton CA 94566
• MDR Report Key: 7637702
• MDR Text Key: 112487265
• Report Number: MW5078034
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CB14-135-40120CW
• Device Lot Number: F170922500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR