MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-06 for ZOLL IVTM QUATTRO CATHETER IC-4593AE 8700-0783-01 manufactured by Zoll Circulation.
[186587798]
The reported complaint of a leaking quattro catheter was confirmed during functional testing. A leak on the catheter's shaft was observed. The investigation findings revealed that the root cause of the reported complaint was due to a small sharp cut at 6 cm away from the distal end of the manifold which is a characteristic of a cutting instrument, likely caused by user error. Visual inspection of the returned catheter was performed and no physical damage was observed. During functional testing, all infusion ports and extension tubes were flushed without resistance. The catheter was connected to a pressurized inflation device and immediately a leak on the catheter's shaft was observed. Thus, confirming the reported complaint. Additionally, the returned quattro catheter was visually inspected under a microscope and a small sharp cut at 6 cm away from the distal end of the manifold was observed. During manufacturing, all catheters are 100% inspected for leaks by subjecting them to pressure testing. Only units that passed are moved to the next process. Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for quattro catheter with lot number 99639.
Patient Sequence No: 1, Text Type: N, H10
[186587799]
The customer reported that on the second day of ivtm therapy, during the rewarming phase, the saline bag was noticed empty and the thermogard console generated an air trap alarm. There were no signs of fluid on the floor or near the patient's bed. There were no issues reported for the start-up kit (suk). The catheter leak was suspected. The catheter was removed and an alternative method was used to complete patient treatment. No device malfunction was reported for the console. No consequences or impact to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00234 |
| MDR Report Key | 9803141 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-10-11 |
| Date Added to Maude | 2020-03-06 |
| 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 KIMTHOA NGUYEN |
| Manufacturer Street | 2000 RINGWOOD AVE, |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Manufacturer G1 | ZOLL CIRCULATION |
| Manufacturer Street | 2000 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOLL IVTM QUATTRO CATHETER |
| Generic Name | CENTRAL VENOUS CATHETER |
| Product Code | NCX |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-02-24 |
| Model Number | IC-4593AE |
| Catalog Number | 8700-0783-01 |
| Lot Number | 99639 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL CIRCULATION |
| Manufacturer Address | 2000 RINGWOOD AVE. SAN JOSE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |