MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-10-12 for VASCUFIL 7/0 30 D/A BLUE CV-1 8886470401V manufactured by Covidien Lp, Formerly Us Surgical.
[3082125]
Procedure: arteriotomy suture of internal common carotid. According to the reporter: the suture broke at half suture. The suture was started again with a new vascufil 7/0, same lot number, starting from the distal point of arteriotomy with continue suture, up to knotting this new thread with the end of previous one. Then, it was performed a reinforcement of the first suture with the second one. When patient was extubated, a sudden right latero-cervical haematoma appeared. Patient was cannulized in emergency and, meanwhile, the haematoma emptying was performed. After the emergency operations to stop bleeding by vessel clamping, it was found a breach (an opening) on the suture from the distal end to the middle knotting point, with an evident break of thread. The fragment of the broken suture were removed and a new suture was performed using the product with different lot number.
Patient Sequence No: 1, Text Type: D, B5
[10235285]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2012-00841 |
| MDR Report Key | 2798829 |
| Report Source | 06 |
| Date Received | 2012-10-12 |
| Date of Report | 2012-10-10 |
| Date of Event | 2012-07-17 |
| Date Mfgr Received | 2012-10-10 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2012-10-23 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MELISSA ZAFFIN |
| Manufacturer Street | 60 MIDDLETOWN AVENUE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034927141 |
| Manufacturer G1 | COVIDIEN, FORMERLY US SURGICAL A |
| Manufacturer Street | 60 MIDDLETOWN AVENUE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VASCUFIL 7/0 30 D/A BLUE CV-1 |
| Generic Name | NON-ABSORBABLE SUTURING PRODUCT |
| Product Code | GAS |
| Date Received | 2012-10-12 |
| Catalog Number | 8886470401V |
| Lot Number | A1K0297X |
| Device Expiration Date | 2016-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP, FORMERLY US SURGICAL |
| Manufacturer Address | 60 MIDDLETOWN AVENUE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2012-10-12 |