MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-07-01 for UNKNOWN SURGIPRO UNKNOWN - SPRO manufactured by Covidien.
[17386283]
Complaint related to the same incident under (b)(4). Procedure type: mitral reconstruction. According to the reporter: the surgeon informs that the sutures break (tear), the needles have no consistency and they are difficult to manipulate. Due to this issue, the patient remained 60 additional minutes with ischemia in the heart. Now the patient has an artificial heart and is about to die. More than 30 minutes delay due to the problem. Damaged to tissue. Additional info requested via email: the sales regional manager and field service manager have visited the surgeon. According to the surgeon, the problem is not a fact a quality problem with the specific lot of suture used during the procedure, but a complaint on the inadequacy of this type of suture and model according to the surgeons criteria. He reported that the needles are not visible, they blend and they are not consistent and the form is not adequate for his needs. Surgipro size 4-0 has a very big needle, the needle is 1 mm shorter, and therefore less precise. The thread is too long, as it separates from the needle and tears the tissue etc. The patient was disconnected, although the death cannot be attributed directly to the suture.
Patient Sequence No: 1, Text Type: D, B5
[17812984]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2014-00494 |
| MDR Report Key | 3924743 |
| Report Source | 01,05,06 |
| Date Received | 2014-07-01 |
| Date of Report | 2014-06-02 |
| Date of Event | 2014-05-31 |
| Date Mfgr Received | 2014-06-02 |
| Date Added to Maude | 2014-07-11 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVENUE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN |
| 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 | UNKNOWN SURGIPRO |
| Generic Name | SURGIPRO SUTURE |
| Product Code | GAS |
| Date Received | 2014-07-01 |
| Catalog Number | UNKNOWN - SPRO |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 60 MIDDLETOWN AVENUE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-07-01 |