MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-01 for LACRICATH LACRIMAL DUCT BALLOON CATHETER LDC213T manufactured by Quest Medical, Inc..
[66515056]
The clinic reported an issue with a lacrimal duct catheter during a procedure. The report stated that the alleged event occurred during a dacroplasty procedure and was inserted into the patient at the time. The report stated that the balloon portion of the device leaked and would not maintain pressure. As a result of the alleged issue, the device was removed and another one was used to successfully complete the procedure. There were no patient complications reported as a result of the alleged issue. The device was returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[67567144]
The sample was examined visually and functionally with no anomalies found. The device performed per specification with no leakage. The device history records for the possible lots were reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2017-00003 |
| MDR Report Key | 6295147 |
| Date Received | 2017-02-01 |
| Date of Report | 2017-02-03 |
| Date of Event | 2017-01-04 |
| Date Mfgr Received | 2017-01-05 |
| Date Added to Maude | 2017-02-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. AMY CLENDENING-WHEELER |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Manufacturer G1 | QUEST MEDICAL, INC. |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LACRICATH LACRIMAL DUCT BALLOON CATHETER |
| Generic Name | LACRIMAL STENTS AND INTUBATION SETS |
| Product Code | OKS |
| Date Received | 2017-02-01 |
| Returned To Mfg | 2017-01-11 |
| Model Number | LDC213T |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-01 |