MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-09 for TR BAND N/A TRB24-REG manufactured by Terumo Medical Corporation.
[182520490]
Expiration date - unknown due to unknown lot number. Udi - unknown due to unknown lot number. Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacture date - unknown due to unknown lot number. (b)(4). The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted. The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record. With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.
Patient Sequence No: 1, Text Type: N, H10
[182520491]
The user facility reported that the involved tr band was used. There was a radial complication that had occurred. The complication was observed 1. 5 hours after the tr band placement and was so severe that it required a fasciotomy. It sounded like either the band was placed too distal to artery entry site and the doctor took a very aggressive angle for access resulting in a proximal vessel entry site. Additional information was received on 21feb2020. The procedure that was performed prior to the tr band being used was a heart catheterization. A 6fr sheath was used. The radial artery was accessed. The tr band was removed, and an hour and a half later, the patient develop symptoms of compartment syndrome. The patient's condition was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1118880-2020-00006 |
| MDR Report Key | 9804763 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-09 |
| 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 | THERESA MUSSAW |
| Manufacturer Street | 950 ELKTON BLVD. |
| Manufacturer City | ELKTON, MD |
| Manufacturer Country | US |
| Manufacturer Phone | 2837866718 |
| Manufacturer G1 | TERUMO MEDICAL CORPORATION |
| Manufacturer Street | 950 ELKTON BLVD. |
| Manufacturer City | ELKTON, MD |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TR BAND |
| Generic Name | CLAMP, VASCULAR |
| Product Code | DXC |
| Date Received | 2020-03-09 |
| Model Number | N/A |
| Catalog Number | TRB24-REG |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO MEDICAL CORPORATION |
| Manufacturer Address | 950 ELKTON BLVD. ELKTON, MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-09 |