MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-10 for LACRICATH LACRIMAL DUCT BALLOON CATHETER 3 MM LDC315T manufactured by Quest Medical, Inc..
[72542026]
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.
Patient Sequence No: 1, Text Type: N, H10
[72542027]
The facility materials manager reported an issue encountered by the physician while using the lacrimal duct catheter. The report stated that the device would not remain inflated. The report stated that the catheter was removed and a second one was used to successfully complete the procedure. There were no patient complications reported as a result of the alleged issue. The catheter was returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[75442257]
Because the complaint sample was a device included in a kit,, there were 2 possible lots of product it could have been. The other possible lot of product is lot 0523966n02 manufacture date 10/26/2016 exp 10/26/2019. Visual examination of the complaint sample found that it had been used. After decontamination, the device was inflated to 8atm. The device remained inflated during pressurization; however, once completed a leak was observed at the tip. The root cause is most likely inadequate adhesive to bond the balloon to the catheter body. The possible product lots were both manufactured prior to manufacturing process improvements implemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2017-00037 |
| MDR Report Key | 6475986 |
| Date Received | 2017-04-10 |
| Date of Report | 2017-04-25 |
| Date of Event | 2017-03-24 |
| Date Mfgr Received | 2017-03-24 |
| Date Added to Maude | 2017-04-10 |
| 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 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 3 MM |
| Generic Name | LACRIMAL DUCT CATHETER |
| Product Code | OKS |
| Date Received | 2017-04-10 |
| Returned To Mfg | 2017-03-29 |
| Model Number | LDC315T |
| Lot Number | 0521446S05 |
| Device Expiration Date | 2019-09-15 |
| 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 | 2017-04-10 |