MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-04-11 for CIAGLIA BLUE DOLPHIN PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET C-PTBS-2700-VT9 manufactured by Cook, Inc..
[18800363]
Additional surgical procedure is not listed in the instructions for use. Additional surgical procedure is not listed in the instructions for use. Product was not returned to assist in our investigation. Appropriate design controls have been completed. Per specification, "for inner cannula and obturator, measure boxed dimensions and confirm overall surface is clean and free from damage or imperfections and that distal tip is smooth with no rough edges. " the instructions for use (ifu) details proper usage and placement techniques as well as the necessary warnings and precautions. The ifu contains the following warning. "anatomic anomalies may make the procedure difficult to perform. The presence of anomalous blood vessels may cause excessive bleeding during the procedure. " quality control measures the length of the inner cannula and obturator and confirms the overall surface is clean and free from damage or imperfections and that the distal tip is smooth with no rough edges. Without the actual complaint device, we are unable to determine what may have led to this failure mode. We will continue to monitor for similar complaints and have notified the appropriate internal personnel. Per the conclusions of quality engineering risk assessment, no further mitigating actions are necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
[18846890]
Info was provided that the physician contacted the rep, advising that the primary procedure went fine; although a decision was made to change the first tube (1820334-2011-00194) with a second one versatube 9mm (1820334-2012-00195). This was done as the first tube was too short, always under fiber optic scope, although that procedure went very well. However, after 4 hours, the pt suddenly suffered complications as the trachea was bleeding due to it being damaged. It was necessary to call a surgeon to repair it in an operating theatre. The intervention took almost 3 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2012-00195 |
| MDR Report Key | 2535942 |
| Report Source | 01,08 |
| Date Received | 2012-04-11 |
| Date of Report | 2012-03-14 |
| Date of Event | 2012-03-13 |
| Date Facility Aware | 2012-03-13 |
| Report Date | 2012-03-14 |
| Date Mfgr Received | 2012-03-20 |
| Device Manufacturer Date | 2011-03-04 |
| Date Added to Maude | 2012-04-17 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, MGR. |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIAGLIA BLUE DOLPHIN PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET |
| Generic Name | KCG DILATOR, TRACHEAL |
| Product Code | KCG |
| Date Received | 2012-04-11 |
| Model Number | NA |
| Catalog Number | C-PTBS-2700-VT9 |
| Lot Number | 2638210 |
| ID Number | NA |
| Device Expiration Date | 2012-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-04-11 |