MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER 830705F manufactured by Edwards Lifesciences, Pr.
[141466054]
One fogarty dilation atrioseptostomy catheter with attached nipro 2. 5 ml syringe was returned for evaluation. Blood was visible on the proximal balloon windings. The balloon and windings were examined and the balloon latex surface appeared deteriorated. No damage to the distal or proximal windings was observed. The balloon was inflated with 3. 6 cc air and the balloon inflated concentric for 5 minutes. The balloon deflated within 1 second. Per specification maximum deflation time from full capacity with air is 5 seconds. The balloon was again inflated using 1. 8 cc water and the balloon inflated concentric and did not leak. The balloon deflated > 15 seconds. Per specification maximum deflation time from full capacity with water is 15 seconds. Balloon testing was performed with lab syringe. Visual examination was performed under microscope at 20x magnification and with the unaided eyes. The lot number was not provided; therefore, a review of the manufacturing records could not be completed. Customer report of balloon deflation issue was confirmed during analysis. An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions. The fogarty catheter is typically used on vessels that are already occluded so the potential for ischemia related to deflation difficulty in this set of circumstances, is less likely. However, deflation difficulty can also impair balloon modulation during use, which has the potential to lead to vascular injury; therefore, the potential for injury is not considered to be remote. It should be noted that the ifu clearly states in the warning section that: use of a highly viscous or particulate contrast medium is not recommended for balloon inflation because the inflation lumen may become occluded. It is unknown whether user or procedural factors may have contributed to the stated event. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
Patient Sequence No: 1, Text Type: N, H10
[141466055]
It was reported that the balloon did not deflate during use. The balloon eventually deflated after a few attempts to deflate. No additional treatment was required when removing the catheter from the patient. Patient demographic information requested but unavailable. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01233 |
| MDR Report Key | 8493821 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-03-15 |
| Date Mfgr Received | 2019-06-17 |
| Date Added to Maude | 2019-04-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LYNN THOMAS |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| Manufacturer G1 | EDWARDS LIFESCIENCES, PR |
| Manufacturer Street | STATE RD INDUS PK 402 KM 1.4 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER |
| Generic Name | FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER |
| Product Code | DXF |
| Date Received | 2019-04-08 |
| Returned To Mfg | 2019-03-24 |
| Model Number | 830705F |
| Catalog Number | 830705F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES, PR |
| Manufacturer Address | STATE RD INDUS PK 402 KM 1.4 ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |