MAUDE Adverse Event Report: QUEST MEDICAL, INC. LACRICATH BALLOON CATHETER; LACRIMAL INTUBATION SET

Model Number DCP315BIT

Device Problems Break (1069); Inflation Problem (1310); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

The hypotube exhibited fatigue as if it had been bent or pushed hard against a bony prominence.Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.

Event Description

The charge nurse reported an issue encountered with the lacricath balloon catheter bilateral set during a procedure.The report stated the procedure was for a bilateral procedure.The physician stated the right eye went fine, but the left side would not dilate because the balloon would not inflate.The report stated the end of the lacricath guide appeared to have broken, puncturing the dilating balloon.The surgeon reported one device was broken and had to reuse the second one, but he was able to finish the procedure.The device was returned to the manufacturer for analysis.There were no patient complications reported as a result of the alleged issue.

• Brand Name: LACRICATH BALLOON CATHETER
• Type of Device: LACRIMAL INTUBATION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: amy clendening-wheeler ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 5262890
• MDR Text Key: 32585016
• Report Number: 1649914-2015-00104
• Device Sequence Number: 1
• Product Code: OKS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2017
• Device Model Number: DCP315BIT
• Device Lot Number: 0493185U02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR