MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-08 for MOLLRING CUTTER MRC4406 manufactured by Vascular Architechs.
[794662]
The mollring cutter device was advanced down the superficial femoral artery. Upon transection, the mollring cutter tip or ring broke and became loose within the superficial femoral artery. Another mollring device was used to grasp the tip and moved the tip for approximately 8cm. A fogarty catheter balloon was then used to remove the tip completely from the superficial femoral artery. The procedure was completed with no adverse effects to the patient.
Patient Sequence No: 1, Text Type: D, B5
[7950126]
During a procedure involving a mollring cutter, the tip or ring broke and became lodged within the superficial femoral artery. The ring was grasped with another mollring device and advanced 8cm to allow a fogarty balloon to completely remove the ring completely from the superficial femoral artery. The procedure was completed with no adverse effects to the patient. The device was evaluated on 1/2/2008. From our evaluation we were able to confirm the reported complaint. When the device was returned, it was confirmed that the proximal ring was detached from the device. The device arm was very difficult to extend. The root cause of the device malfunction remains inconclusive at this time. Vascular architechs was acquired by lemaitre vascular inc. In september 2007. For this reason, this report is being submitted by lemaitre vascular.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220948-2008-00001 |
| MDR Report Key | 998518 |
| Report Source | 05 |
| Date Received | 2008-02-08 |
| Date of Report | 2008-01-21 |
| Date of Event | 2008-12-24 |
| Date Mfgr Received | 2008-01-02 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2009-05-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 63 SECOND AVENUE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOLLRING CUTTER |
| Generic Name | MOLLRING CUTTER |
| Product Code | DWX |
| Date Received | 2008-02-08 |
| Returned To Mfg | 2008-01-02 |
| Model Number | MRC4406 |
| Catalog Number | MRC4406 |
| Lot Number | 050107 |
| Device Expiration Date | 2009-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VASCULAR ARCHITECHS |
| Manufacturer Address | NASHVILLE TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-02-08 |