MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-14 for STOCKERT M-5463-320 S7036 manufactured by Stockert Gmbh.
[26317193]
The hardware investigation has begun but it has not been completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. The 'suspected medical device' reported in this report is not marketed in usa or approved by the fda. However, it is being reported as biosense webster considers this as a similar device to stockert 70 system approved under pma # p990071. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[26317194]
It was reported that a patient underwent an atrial fibrillation procedure with a stockert j70 rf generator system and a low temperature without an error occurred. The temperature of the smart touch catheter was displaying 5 degree celsius during the ablation. The cable was reconnected and changed but the issue continued. The issue was resolved by changing the catheter to another one. The procedure was completed without patient consequence. Additional information was requested to obtain clarification to this complaint. However, no further information has been made available. Based on the information available, this is indicative of a reportable event as the temperature displayed 5 degrees celsius during ablation which is below the minimum temperature allowed to start ablation. This could potentially cause patient injury.
Patient Sequence No: 1, Text Type: D, B5
[34411526]
Additional information was also received on october 27, 2015 that the stocker did not start ablation when the temperature was reading 5 degrees celsius. It is possible that the temperature displayed 5 degrees celsius after ablation started however it cannot be confirmed. Due to the august 2015 fda maintenance where the 3500a codes were updated, the 3500a codes will be added until the biosense webster system is also updated. Therefore the following codes apply: (b)(4). It was reported that a patient underwent an atrial fibrillation procedure with a stockert j70 rf generator system and a low temperature without an error occurred. The issue was resolved by changing the catheter to another one. No device malfunction found. The device history record review verifies that the device was manufactured in accordance with documented specification and procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612355-2015-00043 |
| MDR Report Key | 5075965 |
| Date Received | 2015-09-14 |
| Date of Report | 2015-08-26 |
| Date of Event | 2015-08-25 |
| Date Mfgr Received | 2015-08-25 |
| Date Added to Maude | 2015-09-14 |
| 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 | SHAHE GARABEDIAN |
| Manufacturer Phone | 9098397362 |
| Manufacturer G1 | STOCKERT GMBH |
| Manufacturer Street | BOETZINGER STRASSE 72 |
| Manufacturer City | FREIBURG, B-W D-79111 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STOCKERT |
| Generic Name | SIMILAR DEVICE S7001, PMA # P990071 |
| Product Code | BXN |
| Date Received | 2015-09-14 |
| Model Number | M-5463-320 |
| Catalog Number | S7036 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STOCKERT GMBH |
| Manufacturer Address | BOETZINGER STRASSE 72 FREIBURG, B-W D-79111 GM D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-14 |