MAUDE Adverse Event Report: COOK, INC. BALLOON DILATOR

Model Number ADVANCE14LP

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

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

Event Date 06/20/2018

Event Type  Injury  

Event Description

After balloon inflation the catheter was being removed from the pt, and the balloon catheter broke off inside the sheath.Sheath was removed along with the broken off piece intact and the entire broken off piece was removed from the pt.

• Brand Name: BALLOON DILATOR
• Type of Device: BALLOON DILATOR
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 7633737
• MDR Text Key: 112306985
• Report Number: MW5078023
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2018
• Device Model Number: ADVANCE14LP
• Device Lot Number: 8652236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR