MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-10-26 for CRE BALLOON DILATATION CATHETER M00558440 5844 manufactured by Boston Scientific Cork Ltd.
[17728246]
On october 2, 2007, it was reported to boston scientific corporation that a tracheal dilatation procedure using a cre dilatation balloon catheter was performed (male patient). According to the complaint. "the balloon was set up using readi-cat 2 contrast medium, advanced through the lma [device] (laryngeal mask airway)... Inflated up to 20mm. " then, when attempting to deflate the balloon after the procedure was completed, the "balloon was unable to deflate completely. " reportedly, the "balloon would not come back through the lma and the lma and [the] balloon had to be removed from the patient with the balloon in the lma partially inflated. " information provided to boston scientific, revealed that at the conclusion of the procedure, there were no patient complications.
Patient Sequence No: 1, Text Type: D, B5
[17968956]
The suspect device has been received but an evaluation has not been performed. Therefore, a failure analysis is not available, and it is not possible to determine the relationship between this device and the cause of the event. An evaluation of the returned device, a review of the device history record and a review of the product family complaint trend report are in progress; results will be provided in a follow-up medwatch report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000122-2007-00026 |
| MDR Report Key | 933946 |
| Report Source | 05,07 |
| Date Received | 2007-10-26 |
| Date of Report | 2007-10-02 |
| Date of Event | 2007-10-01 |
| Date Mfgr Received | 2007-10-02 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2007-12-14 |
| 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 Contact | KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORK, LTD. |
| Manufacturer Street | CORK BUSINESS & TECHNOLOGY PK MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRE BALLOON DILATATION CATHETER |
| Product Code | KCG |
| Date Received | 2007-10-26 |
| Returned To Mfg | 2007-10-16 |
| Model Number | M00558440 |
| Catalog Number | 5844 |
| Lot Number | 9783920 |
| ID Number | NA |
| Device Expiration Date | 2010-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 933777 |
| Manufacturer | BOSTON SCIENTIFIC CORK LTD |
| Manufacturer Address | CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-26 |