MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-11-13 for PLASMABLADE 4.0 GENERAL SURGERY PS200-040 manufactured by Medtronic Advanced Energy, Llc.
[5109112]
During a pacemaker generator change out procedure, the physician cut through a pacemaker lead with the plasmablade. The physician reported that he was trying to free the leads in the pacemaker pocket when he saw a spark and realized he had cut through a lead. Damaged lead was replaced with no patient impact. Pulsar system was on settings cut 5, coag 6. The lead was an attain 4196 lv.
Patient Sequence No: 1, Text Type: D, B5
[12561342]
Product event # (b)(4). Evaluation, (method): (result), (conclusion): device returned and analysis currently underway. Pending analysis results. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37765374]
Product analysis #(b)(4) investigation plan: visual inspection functional inspection (if applicable) lhr review complaint device details: device name: plasmablade? 4. 0 product number: ps200-040 lot number: unknown expiration date: unknown quantity returned: 1 testing performed: device packaging inspection: plasmablade? 4. 0 pink received in a cardboard box within a single large biohazard bag and wrapped in a towel and what appears to be a pacemaker lead within a single biohazard bag. No original packaging returned therefore it is not possible to confirm the device information that is listed in gch nor is it possible to confirm the device that was sent back as the reported complaint device. No paperwork was included. Device visual inspection: device is used with blood on handle, body and cord. Charring of the electrode present. All components appear in place and intact. Pacemaker lead damage, figure # 1 and figure # 2. Both cut and coag buttons have a definitive tactile feel. Functional inspection: since the reported event has confirmed that the technique of the surgeon was the cause of damage to the lead the extent of the functional inspection was to ensure that the device was operating as expected. The plasmablade? 4. 0 was connected to the complaint lab pulsar? Ii generator and the expected e5 error code, end of life, was displayed indicating that the device had been successfully activated by a pulsar? Ii generator prior to complaint investigation. The device was tested for functionality, per 42-10-1020 rev. C; the device was activated in grounded saline at cut setting? 2 and coag setting-1, settings used for testing during manufacturing, with acceptable results. The device was further tested for functionality at cut settings 1 thru 10 and coag settings 1 thru 10 with acceptable results. The device was tested for performance using chicken, per 31-10-1368 rev. D, for 10 minutes total activation time enabling alternation between modes at cut setting-10 for 5 minutes and coag setting-10 for 5 minutes with acceptable results. The device was tested utilizing the same settings that were utilized during the case at cut setting-5 and coag setting-6 with acceptable results. ? The device is acceptable if the? Glow? Around the edge of the blade is observed and an audible high pitch noise is heard coming from the generator when both buttons cut and coag are actuated? , which was observed during functional inspection of the complaint device. Lhr review: a review of the lhr is not possible as the device lot number is listed in gch as unknown. Investigation conclusion: the complaint is confirmed for the? Damaged pacemaker leads? Issue that was reported in the complaint description based upon the returned damaged lead that was returned with the device. The device was tested for functionality and performance and met the product specifications with acceptable results. The device functioned as intended and responded normally during functional inspection, in grounded saline, chicken testing, and when connected to the generator for all activations. The failure the customer experience was unable to be reproduced within the complaint laboratory environment. The complaint that the customer experienced was visually confirmed via the damaged pacemaker lead that was included with the complaint device as the lead appears to have been cut and has exposed metal within the lead. A likely cause of the failure that the customer experienced as indicated in the complaint description is that the technique on the surgeon was the cause of the damaged lead as the physician was reportedly trying to free up the leads in the pocket when he saw a spark and realized he had cut through a lead. The complaint will be tracked and trended in gch. Plasmablade? 4. 0? Ifu? Lbl-000165? Warnings the use of electro-surgery in the presence of internal or external active implants is potentially hazardous. Interference from the electrical current can cause device malfunction. Consult the active implant manufacturer for further information before proceeding with the surgery. Direct contact with implanted leads can cause physical damage to the leads. Exercise caution around leads associated with any active implant; particularly those with thin insulation.
Patient Sequence No: 1, Text Type: N, H10
[37765375]
During a pacemaker generator change out procedure, the physician cut through a pacemaker lead with the plasmablade. The physician reported that he was trying to free the leads in the pacemaker pocket when he saw a spark and realized he had cut through a lead. Damaged lead was replaced with no patient impact. Pulsar system was on settings cut 5, coag 6. The lead was an attain 4196 lv.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226420-2014-00109 |
| MDR Report Key | 4247496 |
| Report Source | 06,07 |
| Date Received | 2014-11-13 |
| Date of Report | 2014-12-03 |
| Date of Event | 2014-10-16 |
| Date Mfgr Received | 2014-12-03 |
| Date Added to Maude | 2014-11-25 |
| 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 | KAYLEE BOISVERT |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal | 03801 |
| Manufacturer Phone | 6038426234 |
| Manufacturer G1 | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASMABLADE 4.0 GENERAL SURGERY |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-11-13 |
| Returned To Mfg | 2014-10-28 |
| Model Number | PS200-040 |
| Catalog Number | PS200-040 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-13 |