MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-16 for POWER-TRIALYSIS SLIM-CATH PRECURVED EXTENSION SHORT-TERM DIALYSIS CATHETER (12F) N/A 5863150J manufactured by Bard Access Systems.
[183564157]
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling. Based on a review of this information, the following was concluded: the complaint that the guidewire was stuck in the catheter and difficult to manipulate was confirmed and the damage observed on the returned sample appeared to be associated with use. One 12f triple-lumen (t/l) trialysis catheter was returned for investigation. The sample exhibited evidence of use. Both the venous and arterial extension legs were clamped. A 70cm guidewire was received separate from the catheter. The guidewire was bent 18 cm and 43 cm from the proximal tip of the wire. A sharp kink was observed approximately 51cm from the proximal tip of the wire. Dry biological residue was observed on the proximal end of the wire. The damage and residue observed on the guidewire appeared to be associated with use. The dimensions of the guidewire were within specification. The vessel dilator was also returned for investigation. The distal tip of the vessel dilator flared to one side. The damage to the vessel dilator appeared to be associated with use and is consistent with abrasion against the guidewire. No manufacturing damage was observed on the returned samples, which indicates that the damaged guidewire was most likely a contributing factor in the reported event. The sections of guidewire that were not kinked or contaminated with residue passed freely through the catheter tip. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[183564158]
It was reported that the patient had a power trialysis implanted via the right internal jugular vein because the shunt was occluded. The guidewire was stuck in the catheter and could not be removed when the physician tried to remove the guidewire after the catheter was inserted into the vessel. Therefore, the catheter and the guidewire were removed together and another kit was used to complete the procedure. The doctor complaints that the guidewire is too hard to manipulate properly when it is inserted into the patient with complex distribution of the blood. There was no reported patient injury. On 1/14/2020 - returned wire is kinked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-04132 |
| MDR Report Key | 9596534 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-11-13 |
| Date Mfgr Received | 2019-12-27 |
| Date Added to Maude | 2020-01-16 |
| 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 | KAYLA OLSEN |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225010 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. -9617592 |
| Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWER-TRIALYSIS SLIM-CATH PRECURVED EXTENSION SHORT-TERM DIALYSIS CATHETER (12F) |
| Generic Name | CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED |
| Product Code | NIE |
| Date Received | 2020-01-16 |
| Returned To Mfg | 2019-12-02 |
| Model Number | N/A |
| Catalog Number | 5863150J |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-16 |