MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Component Incompatible (1108); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported the device presents difficulty to use the guidewire.Delay in procedure.Additional information received 04 august 2023: initially, it was noted that the guidewire of the 4fr single lumen kit was different from the others used.The puncture was performed, but the guidewire failed to advance, as it was noted a difficult to slide it.Upon removal it got off completely tortuous.It was punctured once again, but with the guidewire damaged there was no progression, making impossible to use it.A new catheter was taken and i used the guidewire from a 3fr kit in the 4fr catheter, procedure was successfully completed after this exchange.Additional punctures needed.Patient got discharged.No medical intervention was needed.It was a pediatric patient being treated with chemotherapy.There was not a break.
Event or Problem Description
It was reported the device presents difficulty to use the guidewire.Delay in procedure.Additional information received 04 august 2023: initially, it was noted that the guidewire of the 4fr single lumen kit was different from the others used.The puncture was performed, but the guidewire failed to advance, as it was noted a difficult to slide it.Upon removal it got off completely tortuous.It was punctured once again, but with the guidewire damaged there was no progression, making impossible to use it.A new catheter was taken and i used the guidewire from a 3fr kit in the 4fr catheter, procedure was successfully completed after this exchange.Additional punctures needed.Patient got discharged.No medical intervention was needed.It was a pediatric patient being treated with chemotherapy.There was not a break.
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.Based on a review of applicable information, the following was concluded: the complaint of difficulty threading the guidewire through the needle was confirmed but the cause is unknown.A single photograph of the distal tip of implicated guidewire was returned for evaluation.The gold coiled end of the guidewire contained deformation where the wire was curled.It was reported that difficulty was encountered when inserting and removing the guidewire from the introducer needle.The difficulty manipulating the wire likely contributed to the observed damage.However, it is unknown what caused the initial difficulty threading the guidewire.Without receipt of the physical sample, dimensional analysis and microscopic observation could not be conducted.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC 4F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17541741
• Report Number: 3006260740-2023-03520
• Device Sequence Number: 18034961
• Product Code: LJS
• UDI-Device Identifier: 00801741027611
• UDI-Public: (01)00801741027611
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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 Expiration Date: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 3174155
• Device Lot Number: REGP3116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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