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 2018-11-20 for SECURACATH SCR-01 400110 manufactured by Interrad Medical.
[129167534]
A 5f triple lumen bard powerpicc hf was sent to interrad medical for evaluation. The catheter was found to be split on the white lumen starting from between the 1cm and 2cm mark, extending to the 3cm mark, approximately 1. 5cm in total length. Only 0. 75cm was split all the way through and was centered on the 2cm mark. Based on the reporter's comments and the fact that the white lumen was the lumen that split, there is a possibility that the wrong lumen was used for power injection. The reporting account did not provide the securacath device or lot number for evaluation. Without those things, an investigation of component and process history or performance of the securacath device could not be conducted. At this time there is no information to indicate that securacath device failed to meet its product specifications. Extensive engineering evaluations have shown that the securacath device is effective at holding a bard power picc catheter in place while not negatively impacting catheter performance. Testing on this specific type catheter has been done and no concerns have been identified. Testing is done with the securacath positioned at the "0" mark on reverse tapered catheters to be the most challenging for flow restriction/catheter compression. Specific testing on bard powerpicc catheters attempted to force a catheter break by purposefully pinching the catheter with the body of the securacath device repeatedly, which would be a worst case scenario of incorrect use of a securacath device, with no catheter failures created. Based on previous testing and the type of split found in the catheter, this was most likely an extrusion/material issue with the catheter and the catheter could have failed without the use of securacath. A search of the maude database shows 11 bard powerpiccs of different sizes and types having reported leaks from (b)(6) 2018 to (b)(6) 2018 without the use of securacath. This demonstrates that damage is seen on bard powerpiccs on the reverse tapered portion from the hub to the 7cm without the use of a securacath device. If the securacath is placed per the ifu and dressed properly afterwards, a catheter leak during use is related to catheter construction and not caused by the securacath device. This represents all of the information that interrad medical was able to obtain at this time. If any new information comes to light in the future a follow up report will be submitted to update this report.
Patient Sequence No: 1, Text Type: N, H10
[129167535]
A 5f triple lumen bard powerpicc hf split and leaked that was being secured with a securacath device. "picc place under normal conditions, 5fr securacath was used. Iv contrast was injected through line on (b)(6) 2011. No way of knowing which lumen was used. Red lumen only one power injectable. Line damage not identified until line was removed. The slit in the white lumen was between the 3 and 4cm mark. Nurse removing line thought the securacath was actually covering the slit/hole. No indications of leaking prior to planned removal. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007795799-2018-00003 |
| MDR Report Key | 8091903 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-10-20 |
| Date Added to Maude | 2018-11-20 |
| 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 | BRIAN BOSCH |
| Manufacturer Street | 181 CHESHIRE LANE SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632256699 |
| Manufacturer G1 | INTERRAD MEDICAL |
| Manufacturer Street | 181 CHESHIRE LANE SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55441 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SECURACATH |
| Generic Name | SUBCUTANEOUS ENGINEERED STABILIZATION DEVICE |
| Product Code | OKC |
| Date Received | 2018-11-20 |
| Model Number | SCR-01 |
| Catalog Number | 400110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERRAD MEDICAL |
| Manufacturer Address | 181 CHESHIRE LANE SUITE 100 PLYMOUTH MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-20 |