MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-02-20 for COOL FLOW IRRIGATION PUMP M-5491-02 CFP002 manufactured by Hei, Inc.
[18209246]
Investigation is still in progress. A supplemental report on device evaluation will be submitted once it is completed.
Patient Sequence No: 1, Text Type: N, H10
[18227915]
It was reported that the tip of a catheter used during a ventricular tachycardia procedure was found in a folded position and was not responding to deflection at the point of attempting to remove the catheter from the patient. When consulted, the biosense webster representative suggested cutting the handle of the catheter to release the tension on the tip, however, it did not resolve the issue. Aortic dissection had to be performed to remove the catheter. Stent placement was used to repair the dissection. Patient's condition has improved. Prognosis was satisfactory. Further information received mentioned that the case was not as severe as initially thought to be. Upon cutting the handle of the catheter to release the tension on the tip, the catheter did not immediately become unfolded. After approximately 5 minutes, the catheter did go back to a relaxed position. Meanwhile, the physician had already performed an aortic dissection and called for a specialist to consult and placed the stent. The information provided mentioned that had they waited a little longer, they could have retrieved the catheter without having to perform the aortic dissection and stenting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721752-2009-00002 |
| MDR Report Key | 1320970 |
| Report Source | 07 |
| Date Received | 2009-02-20 |
| Date of Report | 2009-01-22 |
| Date of Event | 2009-01-22 |
| Date Mfgr Received | 2009-01-22 |
| Date Added to Maude | 2009-02-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | GAIL HAPNER |
| Manufacturer Street | 15715 ARROW HWY |
| Manufacturer City | IRWINDALE CA 91706 |
| Manufacturer Country | US |
| Manufacturer Postal | 91706 |
| Manufacturer Phone | 9098398938 |
| Manufacturer G1 | HEI, INC |
| Manufacturer Street | 4801 NORTH 63RD. ST. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOL FLOW IRRIGATION PUMP |
| Generic Name | PUMP, CIRCULATING-FLUID, LOCALIZED HEAT |
| Product Code | KQT |
| Date Received | 2009-02-20 |
| Model Number | M-5491-02 |
| Catalog Number | CFP002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEI, INC |
| Manufacturer Address | BOULDER CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-02-20 |