MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-22 for MDT2168104 manufactured by Medline Industries Inc..
[124575380]
It was reported that during a percutaneous coronary intervention (pci) procedure the physician noted that the opened vessel had "shut down. " the physician performed a thrombectomy and reportedly removed linted or material from the vessel. The patient was not under general anesthesia at the time of the incident. The pci procedure was completed without further reported incident. After an unidentified period of time, the facility contact noted that the patient was required to return to the procedure room for additional intervention as the vessel was found to have occluded. It was not indicated if or towel material was found or required to be removed from the vessel during the second, unidentified, cardiac procedure. No additional information related to the second, unidentified, cardiac procedure was reported to the manufacturer. The manufacturer did not receive information indicating that the originally reported linted or material caused and/or contributed to the second, unidentified, cardiac procedure. Although samples from various lots were returned, the original or towel sample involved in this incident was not returned to the manufacturer for evaluation. Investigation of the returned samples noted loose threads on the or towel with no linting noted. A root cause could not be determined. Due to the reported incident and the need for medical intervention to remove the linted or material from the vessel, this medwatch is being filed. If additional information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[124575381]
It was reported that during a percutaneous coronary intervention (pci) procedure or towel material was found to have linted into a vessel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00111 |
| MDR Report Key | 7991555 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-22 |
| Date of Report | 2018-10-22 |
| Date of Event | 2018-09-01 |
| Date Mfgr Received | 2018-09-25 |
| Date Added to Maude | 2018-10-22 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TOWEL,OR,DSP,ST,GREEN,DLX,4/PK,20PK/CS |
| Product Code | FRL |
| Date Received | 2018-10-22 |
| Catalog Number | MDT2168104 |
| Lot Number | 18GB0443 |
| 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 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-22 |