MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-17 for BLOM-SINGER ADJUSTABLE BI-FLANGED FISTULA FM1004 manufactured by Helix Medical, Llc.
[6049731]
While the patient was under general anesthesia in the operating room, the physician was placing a fistula device, catalog number fm1004, from an unknown lot number. The catheter was placed with no difficulties, however the locking loop "didn't lock easily on the device due to saliva. The physician used a piece of silk to tie the beaded stem to the catheter. The device was placed and the patient was then taken to post-op care where they were tested for leakage. They found leakage of the device, and went in to tighten the device using hemostats. About 2 to 3 beads in, the device snapped. " the partial device is still in the patient, who remains in the hospital for an unrelated reason. The next day, the physician used a bronchoscope and removed the device, and a new fistula was placed in without a problem, no leakage. Device will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
[14382946]
As stated in the product's instructions for use (ifu), the event of leakage is a documentation/known complication: "intractable leakage around the prosthesis, requiring adjustment or re-fitting of the prosthesis, or other surgical/prosthetic of medical management options. " also documented in the ifu: "accidental aspiration of the prosthesis into the airway, which may require removal by a physician. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025182-2015-00004 |
| MDR Report Key | 4927669 |
| Report Source | 05 |
| Date Received | 2015-07-17 |
| Date of Report | 2015-07-17 |
| Date of Event | 2015-07-01 |
| Date Mfgr Received | 2015-07-01 |
| Date Added to Maude | 2015-07-22 |
| 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 | BELINDA JACKSON |
| Manufacturer Street | 1110 MARK AVE. |
| Manufacturer City | CARPINTERIA CA 93013 |
| Manufacturer Country | US |
| Manufacturer Postal | 93013 |
| Manufacturer Phone | 8055765308 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLOM-SINGER ADJUSTABLE BI-FLANGED FISTULA |
| Generic Name | FISTULA PROSTHESIS |
| Product Code | EWL |
| Date Received | 2015-07-17 |
| Returned To Mfg | 2015-07-09 |
| Model Number | FM1004 |
| Catalog Number | FM1004 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HELIX MEDICAL, LLC |
| Manufacturer Address | CARPINTERIA CA 93013 US 93013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-17 |