MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERGLIDE PRO; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/12/2024

Event Type  Injury  

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.

Event Description

It was reported via medwatch "while attempting a powerglide pro midline catheter via ultrasound guided, there was a malfunction of the catheter.The rn had a visual of vein and aligned the q-magnetic box over the vein.The rn advanced the guidewire with no resistance, then while advancing the catheter, it stopped moving before being deployed.The rn pulled the catheter back to the starting point with no issues, then tried to retract the guidewire, but it would not move.After several attempts to retract the wire the rn spoke with the charge rn and explained the catheter was stuck in the patients' arm.Vat team was called along with manufactory representative.An x-ray was ordered, and it was found that the guidewire was curled backwards.The patient had intra-op removal of the guide wire by vascular surgery.".

• Brand Name: BARD POWERGLIDE PRO
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19060906
• MDR Text Key: 339608783
• Report Number: 3006260740-2024-01547
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention