MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-12 for DYNJ46134C manufactured by Medline Industries Inc..
[114050980]
It was reported that during a left heart catheterization with intervention, upon removal of the catheter from the patient, a "thrombus" was noted on the catheter, reportedly from the linting of blue or towel. Per report, the blue or towel was inspected before use and linting was not identified at that time. It was denied that the towel was used to wipe the catheter. Per report, the facility was able to pull out the "thrombus"on the catheter; however, was unable to determine if any lint remained in the patient. The patient did not require additional sedation as a result of this incident. The patient was discharged to home following the procedure. There was no serious injury reported. Due to the reported incident and in an abundance of caution, this medwatch is being filed. The sample was discarded and was not returned for evaluation. A root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[114050981]
It was reported that during a left heart catheterization with intervention, upon removal of the catheter from the patient, a "thrombus" was noted on the catheter, reportedly from the linting of blue or towel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00038 |
| MDR Report Key | 7682779 |
| Date Received | 2018-07-12 |
| Date of Report | 2018-07-12 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-06-21 |
| Date Added to Maude | 2018-07-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | CATH N0 1 STRL MMC PACK |
| Product Code | OES |
| Date Received | 2018-07-12 |
| Catalog Number | DYNJ46134C |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-12 |