MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-04 for DYNJ0543507AA manufactured by Medline Industries Inc..
[137716146]
It was reported that, during a diagnostic heart catheterization procedure, lint went into a patient's coronary artery and became lodged into the distal left anterior descending coronary artery. The surgeon reported that lint was not noted on the wire, but a lucency was visualized in the coronary artery after the percutaneous coronary intervention (pci) was complete. The physician feels that a piece of lint was advanced over the wire and into the artery causing a problem in an area that did not have any noted disease. The reported incident did cause an unspecified injury to the patients left anterior descending artery (lad) and prolonged the time it took to complete the procedure which increased the patient's exposure to radiation. The pci procedure was completed without further reported incident; however after an unidentified period of time, the facility contact noted that the patient was required to return to the emergency room (er) for follow-up care due to chest pain. The physician reported that the patient is doing fine at this time. The patient was not under general anesthesia at the time of the incident. It was not indicated if the operating room (or) towel material was found or required to be removed from the vessel. Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further patient details to the manufacturer. The manufacturer did not receive information confirming that the reported linted or towel material caused and/or contributed to procedure. No additional information was available at the time of this report. The sample of the reported towel was not returned to the manufacturer for evaluation. A root cause could not be determined. Due to the reported incident and the need for medical intervention, this medwatch is being filed. If additional information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[137716147]
It was reported that during a diagnostic heart catheterization procedure or towel material was thought to have linted into a vessel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2019-00006 |
| MDR Report Key | 8386963 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-04 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-02-20 |
| Date Mfgr Received | 2019-02-25 |
| Date Added to Maude | 2019-03-04 |
| 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 | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ANGIOGRAPHIC PACK II-LF |
| Product Code | OEQ |
| Date Received | 2019-03-04 |
| Catalog Number | DYNJ0543507AA |
| 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. Required No Informationntervention | 2019-03-04 |