MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-27 for BIB BALLOON IN BALLOON CATHETER 420 BB013 manufactured by Numed, Inc..
[140153793]
The catheter was not returned for evaluation, and the report stated that the distributor did not expect to get any additional information from the user facility. The lot number of the complaint device was not provided. It was narrowed down to two possible lot numbers and the device history records of both were reviewed. There were no issues found with either of the dhrs. A comparative catheter that has the same balloon diameter and labeled rbp was pulled and tested for balloon compliance/rbp. The balloon was immersed in a body temperature water bath and the outer balloon inflated in 1 atm increments until failure. The balloon ruptured at 11 atm, which is well above the labeled rbp of 5atm for this balloon diameter. According to the initial report received from the user facility / distributor, this catheter was being used to place a covered cp stent in an unapproved location, which is an off label use. This bib was placing a covered cp stent in a lvad outflow cannula.
Patient Sequence No: 1, Text Type: N, H10
[140153794]
As per the report from the hospital/bis - "the bib broke. Physician was doing a procedure with a covered cp stent 614309. The balloon burst, however they got it out of the patient and the procedure went well. The outer balloon burst. The physician was doing lvad outflow cannula stenting. An inflation device with pressure gauge was used. A second bib was used to complete the procedure. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2019-00007 |
| MDR Report Key | 8455665 |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2019-03-20 |
| Date Added to Maude | 2019-03-27 |
| 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 | MS. NICHELLE LAFLESH |
| Manufacturer Street | 2880 MAIN STREET |
| Manufacturer City | HOPKINTON NY 12965 |
| Manufacturer Country | US |
| Manufacturer Postal | 12965 |
| Manufacturer Phone | 3153284491 |
| Manufacturer G1 | NUMED, INC. |
| Manufacturer Street | 2880 MAIN STREET |
| Manufacturer City | HOPKINTON NY 12965 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12965 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIB BALLOON IN BALLOON CATHETER |
| Generic Name | STENT PLACEMENT CATHETER |
| Product Code | NVM |
| Date Received | 2019-03-27 |
| Model Number | 420 |
| Catalog Number | BB013 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUMED, INC. |
| Manufacturer Address | 2880 MAIN STREET HOPKINTON NY 12965 US 12965 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-27 |