MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-17 for ZOLL IVTM QUATTRO CATHETER IC-4593AE 8700-0783-40 manufactured by Zoll Circulation.
[188242336]
The reported complaint "the quattro catheter (lot # 79909) leak" was confirmed. Leak was observed at the proximal end of distal balloon during functional leak test. The root cause for the reported complaint resulted from a circumferential tear, which was possibly caused by a latent material defect; however, user mishandling cannot be ruled out. Visual examination of the returned catheter was performed and found no physical damage to the catheter. Dried blood residue was observed on the catheter's balloons and in/out luered tubings. Functional flushing test of the returned catheter was performed. All infusion ports and extension tubes were flushed. A circumferential tear was observed at the proximal end of distal balloon; thus, confirming the reported complaint. The catheter balloon was inspected under the microscope to confirm the tear noted during functional leak test. It is unlikely that the defective catheter was shipped. 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 information related to the reported complaint, and there was no similar complaint reported for quattro catheter with lot number 79909. Physician did not attribute the patient's death to the use of catheter; the condition of the patient was critical, and she died due to an ongoing condition/illness. Event of death was serious. Insertion of 250 ml of sterile saline over 1h in the patient's vasculature could not potentially harm the patient. Administration of sterile saline i. V. Up to 1. 5 l is one of the common methods of treatment at the hospitals. In agreement with the customer, no patient injury or death attributable to zoll product.
Patient Sequence No: 1, Text Type: N, H10
[188242337]
A (b)(6) old female patient was hospitalized and received ivtm treatment for accidental hypothermia. A quattro (lot # 79909) was smoothly inserted into the right femoral vein. The patient's body temperature was 29? C, and the thermogard xp ivtm system was set to a target temperature of 33? C. During the warming phase, after 1 hour of the ivtm therapy when the patient's body temperature was still 29? C, the thermogard xp ivtm system generated an "air trap" alarm. The user noticed that the saline bag was half empty. However, there were no traces of fluid observed on the patient's bed, floor, or the console. Therefore, catheter leak and infusion of 250 milliliters of saline into the patient's body were suspected. No blood tinge was observed in the tubing, and the catheter was not replaced. There was no device malfunction on the thermogard console. The patient passed away, but it is unknown how long after the initiation of the ivtm treatment, the patient was pronounced dead. As per customer, the cause of death was due to the patient's illness, unrelated to the catheter and the ivtm system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00264 |
| MDR Report Key | 9845188 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2018-01-22 |
| Date Added to Maude | 2020-03-17 |
| 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. KIM THOA NGUYEN |
| Manufacturer Street | 2000 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4192922 |
| 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 | 2020-03-17 |
| Returned To Mfg | 2020-02-27 |
| Model Number | IC-4593AE |
| Catalog Number | 8700-0783-40 |
| Lot Number | 79909 |
| 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 | 2020-03-17 |