MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2011-11-23 for HARRISON FETAL BLADDER STENT SET J-HFBS-503540 manufactured by Cook Urological Inc.
[2510517]
Professor (b)(6) has been using the harrison fetal bladder stent for years and he also uses this in the chest for pleural effusions and ccem. However over the past year he said the stent doesn't stay in place any longer than a few days or a week at the very most before it becomes loose and he has to carry the procedure out again or in some cases he ends up using a rocket version which stays in place longer but is a much harder and brutal procedure to perform. Professor (b)(6) attended the thirty-third fetoscopy working group meeting in (b)(6) where he said he spoke to many of his colleagues from all over the world who said the exact same thing and several said they no longer use our stent for that reason. Even (b)(6) team said they have stopped using it. He did say that our system is fantastic for insertion but at the moment is not reliable. He had a patient whom had one placed on friday and came back this morning for a scan and it was out already. He also mentioned something about a randomized trial carried out recently on using the stent for the bladder and that the results did not show that it offered any benefit. He did ask if we do it in different sized or if we had it with the pigtails in a slightly tougher material.
Patient Sequence No: 1, Text Type: D, B5
[9569810]
A complete investigation cannot be performed as the product will not be returned for evaluation. Follow up conversations with the physician indicate that the fetal bladder stent was being used off label for thorax drainage. The stent is intended to be used in the fetal bladder for fetal urinary tract decompression following the diagnosis of fetal postvesicular obstructive uropathy in fetuses of 18 to 32 weeks gestational age as approved in (b)(4). The physician was using the stent in the thoracic cavity for draining fluid from the chest. Our instructions for use clearly state the intended use of this device and warn that the harrison fetal bladder stent is designed and intended for decompression of the fetal urinary tract. There are no data regarding this stent's safety and effectiveness in decompressing, draining, or treating other fetal cavities or conditions. The device being used off label has caused the customer's difficulty to occur. We will instruct the customer on the proper use of the fetal bladder stent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2011-00043 |
| MDR Report Key | 2361597 |
| Report Source | 01,05,07 |
| Date Received | 2011-11-23 |
| Date of Report | 2011-11-22 |
| Date Facility Aware | 2011-10-24 |
| Report Date | 2011-10-24 |
| Date Mfgr Received | 2011-10-24 |
| Date Added to Maude | 2011-12-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS KILANDER |
| Manufacturer Street | 1100 WEST MORGAN |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARRISON FETAL BLADDER STENT SET |
| Generic Name | MPR STENT, BLADDER, FETAL |
| Product Code | MPR |
| Date Received | 2011-11-23 |
| Catalog Number | J-HFBS-503540 |
| Lot Number | UNKNOWN |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL INC |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2011-11-23 |