MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERPICC SOLO2 5F 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that "introducer will not slide in as expected.Customer says it is causing trauma to the skin and vessel because of force needed to insert the device".Additional information received 04/07/2023: opened another introducer kit and placed the line.There were no complications secondary to the vessel trauma.
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported by the customer that "introducer will not slide in as expected.Customer says it is causing trauma to the skin and vessel because of force needed to insert the device.Additional information received 04/07/2023: opened another introducer kit and placed the line.There were no complications secondary to the vessel trauma.
Additional Manufacturer Narrative
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 complaint of difficulty inserting the introducer sheath was confirmed but the cause is unknown.One 5 fr x 7 cm microez microintroducer was returned for evaluation.The slight bend in the shaft of the dilator and sheath was noted.Deformation at the distal end of the sheath was observed.A single photograph of the implicated 5fr x 7cm microez microintroducer was also provided.The photo sample corresponded with the returned physical sample.Microscopic inspection of the deformed sheath tip region revealed a section to be bunched inwards.Blood residue was present at the damaged section.Evidence of a sheath tip taper was observed.A review of the manufacturing records did not reveal evidence of a manufacturing related root cause.Possible contributing factors could include too small of an incision, a steep insertion angle, a poor transition of the introducer sheath to the dilator, or damage to the sheath prior to use.Sheath damage can be minimized by simultaneously advancing the sheath and dilator as a single unit using a rotational motion.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.The damage present on the micrintroducer sheath is indicative of a difficult insertion; therefore, the complaint is confirmed but the exact contributing factors remain unknown.

• Brand Name: BARD POWERPICC SOLO2 5F 3CG
• 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: 16769483
• Report Number: 3006260740-2023-01426
• Device Sequence Number: 3252865
• Product Code: LJS
• UDI-Device Identifier: 00801741223938
• UDI-Public: (01)00801741223938
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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): 06/19/2023

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: CK001028
• Device Lot Number: REGZ0186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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