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 2016-07-29 for GUIDANCE HANDPIECE 5300 manufactured by Halt Medical, Inc..
[50816010]
Investigation results showed no evidence of a manufacturing problem with the device. Evidence showed that the handpiece was rotated/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. An x-ray taken of the patient did not identify the presence of a needle fragment.
Patient Sequence No: 1, Text Type: N, H10
[50816011]
An electrode from the guidance handpiece (model number 5300, lot number t160407) broke during the procedure at (b)(6) hospital with dr. (b)(6). The event occurred during handpiece placement into a 5cm fibroid that the doctor considered tough. The dr. Deployed (1. 5cm) and felt resistance. While retracting the array, the dr. Had difficulty and stated he felt a snap. This occurred after the 11th ablation. The handpiece was withdrawn from the patient for inspection and it would not deploy past 1. 5cm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006443171-2016-00004 |
| MDR Report Key | 5835081 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-29 |
| Date of Report | 2016-07-29 |
| Date of Event | 2016-07-05 |
| Date Mfgr Received | 2016-07-05 |
| Device Manufacturer Date | 2015-01-23 |
| Date Added to Maude | 2016-07-29 |
| 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 | 2016-07-29 |
| Returned To Mfg | 2016-07-06 |
| Model Number | 5300 |
| Catalog Number | 5300 |
| Lot Number | 160407 |
| Device Expiration Date | 2018-04-29 |
| 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 | 2016-07-29 |