MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (18G) (10CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by the customer, powerglide was placed without issue, guidewire and catheter were advanced smoothly without resistance.After the safety was activated, customer noticed that the guidewire tip was half its normal size.Initially the customer thought the wire broke, but after further examining the device noticed the guidewire was tangled up inside the clear house unit of the powerglide.The entire wire was in the device and no wire was left in the patient.
Event or Problem Description
It was reported by the customer, powerglide was placed without issue, guidewire and catheter were advanced smoothly without resistance.After the safety was activated, customer noticed that the guidewire tip was half its normal size.Initially the customer thought the wire broke, but after further examining the device noticed the guidewire was tangled up inside the clear house unit of the powerglide.The entire wire was in the device and no wire was left in the patient.
Additional 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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), photo sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of guidewire not advancing is confirmed but the exact cause remains unknown.Four photos of a powerglide pro device were provided for evaluation.The photos show two devices.One device contains blood residue and an advanced purple slider and the second device does not appear to have blood residues.The first device contained a decoupled guidewire within the housing which likely contributed to the wire not advancing past the needle tip.The second device was shown to have the guidewire advanced without any apparent issues.Based on the information provided, possible contributing factors include resistance between components and advancement against tissue resulting in decoupling of the guidewire and slider.Since the guidewire was observed to be decoupled, the complaint is confirmed but the exact cause remains unknown at this time.H3 other text: evaluation findings are in section h11.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (18G) (10CM)
• Common Device Name: 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 olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16209724
• Report Number: 3006260740-2023-00063
• Device Sequence Number: 5416245
• Product Code: FOZ
• UDI-Device Identifier: 00801741142659
• UDI-Public: (01)00801741142659
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F118100T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown