MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-16 for SWAN-GANZ BIPOLAR PACING CATHETER (FOR FEMORAL INSERTION) D97130F5 manufactured by Edwards Lifesciences Pr.
[186020341]
One d97130f5 with monoject limited volume syringe and non-edwards contamination shield were returned for examination. The reported event of pacing issue was confirmed. The proximal electrode circuit was found to be open. A cut down on the catheter body found the proximal lead wire was broken approximately 1. 8cm proximal of the distal tip. Insulation was not present on the lead wire at the location of damage. The distal electrode circuit was found to be continuous. The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage. No visible abnormality was observed from the catheter body. A review of the manufacturing records indicated that the product met specifications upon release. An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint. Swan-ganz pacing thermodilution (td) catheters serve as diagnostic and therapeutic tools in the management of critically ill patients. There are multiple failure modes that may require the exchange of a pacing catheter. Since proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires, care should be exercised when handling the catheter. Stretching, kinking, or forceful wiping of the catheter may result in damage. After stable pacing has been confirmed, the proximal end of the catheter should be secured to the insertion site to prevent undue movement that could result in tip dislodgment and loss of capture, or catheter migration. Care should be taken not to kink the catheter body when securing it. In this complaint, it could not be determined if procedural factors or device handling may have contributed to the reported 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. Udi # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186020342]
It was reported that the pacing catheter used on an (b)(6) female patient, did not capture. Prior to exchanging the catheter, the box and the pacer wires were changed. A new catheter was used and they were able to continue with the case. No patient complications were reported. Edwards lifesciences was notified of this event through a (b)(4) report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10983 |
| MDR Report Key | 9838352 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-16 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-12-01 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-06-15 |
| Date Added to Maude | 2020-03-16 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWAN-GANZ BIPOLAR PACING CATHETER (FOR FEMORAL INSERTION) |
| Generic Name | CATHETER, FLOW DIRECTED |
| Product Code | DYG |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-03-11 |
| Model Number | D97130F5 |
| Catalog Number | D97130F5 |
| Lot Number | 62290514 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |