MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2018-06-08 for SECURACATH manufactured by Interrad Medical.
[110577737]
Follow up information was gathered from the account and found all incidents occurred over a 3-4-month period involving three single lumen and one double lumen bard solo 2 catheters placed by the oncology team. The follow up information also included the following description of events: picc would not flush or bleed back after a week in situ. X-ray showed "kink within proximal upper arm". Unable to flush or bleed picc. Chest x-ray showed kink in catheter. Picc leaked at site during ct scan contrast injection. "picc clearly kinked under the skin easily felt the loop. " the picc leaked at site during chemotherapy administration. Chemo stopped and linogram with contrast found leakage from "loop" underneath the skin. The reporting account did not provide physical (devices or catheters) or identification (lot or size) evidence. Without those things an investigation of component and process history or performance of the devices could not be conducted. At this time there is no information to indicate that securacath device failed to meet specifications or had any involvement with the kinking and/or extravasation described in these reports. The securacath device makes contact with a catheter within a 2 cm soft elastomer shaft lock, and with two alloy atraumatic anchoring components. The shaft lock is located outside of the patient's body approximately 1 cm from insertion site. The securacath's alloy atraumatic anchoring components interact with the catheter when entering at the insertion site and resting in the subcutaneous layer of skin (2-4 mm below surface). The anchors are blunt and were designed with consideration of catheter wear. Engineering evaluations have shown that the securacath device is effective at holding a bard solo power picc catheter in place while not negatively impacting catheter performance. If the securacath is placed per the ifu and dressed properly afterwards, kinking should not occur. A catheter leaking after being kinked is related to catheter construction and not related to use of a securacath device. There are a number of factors that could have led to this event, including catheter placement, site care, and catheter construction. A maude database search for (b)(6) 2017 to (b)(6) 2018 has shown no less than 6 reported incidences of leaking using a bard powerpicc catheters without a securacath. 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
[110577738]
Interrad received the following descriptions: kinked picc with securacath in situ, replaced with new picc. Kinked picc with securacath in situ, replaced picc kinked picc with securacath + rupture and extravasation of ct contrast at point of kink. Picc sent off for analysis, awaiting results from bard kinked picc with securacath + rupture and extravasation of chemotherapy at point of kink. Picc sent off for analysis, awaiting results from bard. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007795799-2018-00002 |
| MDR Report Key | 7584229 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2018-06-08 |
| Date of Report | 2018-06-08 |
| Date of Event | 2018-01-02 |
| Date Mfgr Received | 2018-03-26 |
| Date Added to Maude | 2018-06-08 |
| 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. PATRICK DECK |
| Manufacturer Street | 181 CHESHIRE LANE SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7634522721 |
| 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 | SECURACATH |
| Product Code | OKC |
| Date Received | 2018-06-08 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Required No Informationntervention | 2018-06-08 |