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 2018-08-22 for DYNJ30213I manufactured by Medline Industries Inc..
[117852045]
It was reported that or towel lint was discovered on a cardiac guidewire during a percutaneous coronary intervention (pci) procedure. According to the facility contact, during the procedure, an unsuccessful attempt was made to pass the pci balloon over the cardiac guidewire. When the cardiac guidewire was removed from the patient, or towel lint was reportedly discovered on the wire. A new cardiac guidewire was obtained without further incident reported. It was reported that there was a delay in opening the artery and that the patient was "on table longer than needed. " information regarding the length of the delay and the overall length of the procedure was not provided. The facility contact denies any serious injury, medical intervention, or follow-up care related to the reported incident. No impact to the patient, the patient's stability, or the patient's plan of care was reported. Only the cardiac guidewire was returned to the manufacturer for evaluation. A small piece of or towel lint was found on a section of the cardiac guidewire. The original or towel sample involved in this incident was not returned to the manufacturer for evaluation. A root cause could not be determined. Due to the reported incident, and in an abundance of caution, this medwatch is being filed. If additional information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[117852046]
It was reported that or towel lint was discovered on a cardiac guidewire during a percutaneous coronary intervention (pci) procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00043 |
| MDR Report Key | 7804359 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-22 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2018-08-02 |
| Date Added to Maude | 2018-08-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | OR TOWEL IN CARDIAC CATH PACK |
| Product Code | OES |
| Date Received | 2018-08-22 |
| Catalog Number | DYNJ30213I |
| Lot Number | 18FDA068 |
| 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. Other | 2018-08-22 |