MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-11-22 for GUIDANCE HANDPIECE 5300 manufactured by Halt Medical, Inc..
[60692200]
Investigation results showed no evidence of a manufacturing problem with the device. Evidence showed that the handpiece was advanced while the needles were deployed causing a sharp bend on the center needle. Retracting the array may have caused the center needle to break. Ifu pl-01-0014, pl-01-0016 and pl-01-0033 provide precautions with regards to positioning and advancing the device while needles are deployed. Training material (pe-00-0102 and pe-00-0103) provides field staff and proctors with precautions with regards to positioning/advancing the device while needles are deployed.
Patient Sequence No: 1, Text Type: N, H10
[60692201]
An electrode from the guidance handpiece (model number 5300, lot number 160810) broke during the procedure at (b)(6) hospital with dr. (b)(6) the uterus was estimated to be 24 weeks in size. The fibroid being treated was estimated to be between 10cm to 15cm in size. During the handpiece positioning, halt field rep. Observed pushing of the handpiece while needles were deployed and cautioned the doctor to not advance while needles are deployed. The field rep asked the doctor after the 6th or 7th ablation to check the needles, and noticed needle #7 was shorter than the others when fully deployed during a test deployment. On nov. 17, 2016, dr. (b)(6) was notified that the missing needle fragment (1. 2cm in length) was not located within the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006443171-2016-00005 |
| MDR Report Key | 6121703 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-22 |
| Date of Report | 2016-11-21 |
| Date of Event | 2016-11-16 |
| Date Mfgr Received | 2016-11-16 |
| Device Manufacturer Date | 2016-08-10 |
| Date Added to Maude | 2016-11-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LOU TATEO |
| Manufacturer Street | 131 SAND CREEK RD. SUITE B |
| Manufacturer City | BRENTWOOD CA 94513 |
| Manufacturer Country | US |
| Manufacturer Postal | 94513 |
| Manufacturer Phone | 9256347949 |
| Manufacturer G1 | HALT MEDICAL, INC. |
| Manufacturer Street | 131 SAND CREEK RD. SUITE B |
| Manufacturer City | BRENTWOOD CA 94513 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94513 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUIDANCE HANDPIECE |
| Generic Name | GUIDANCE HANDPIECE |
| Product Code | HFG |
| Date Received | 2016-11-22 |
| Returned To Mfg | 2016-11-17 |
| Model Number | 5300 |
| Catalog Number | 5300 |
| Lot Number | 160810 |
| Device Expiration Date | 2018-08-10 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALT MEDICAL, INC. |
| Manufacturer Address | 131 SAND CREEK RD. SUITE B BRENTWOOD CA 94513 US 94513 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-22 |