MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 4F SL MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that attempt was made to place 3cg sherlock picc line in right basilic vessel.Vessel was accessed with blood return.Micropuncture wire inserted through access needle.Resistance was met and i immediately stopped advancing the wire.Tried to remove the wire and met resistance so stopped and tried to remove the wire and needle together and still could not remove wire.Needle was removed with wire left in place.Ir called to assess patient.Fluoroscopy was used and wire was shown to have looped and there was a knot at end.It was recommended to put dilator over wire to try to straighten out wire.The wire did start coming out and was pulled out by doctor together with the dilator.The wire was shredded and fluoro was taken and a small piece of the wire was retained in the arm.Doctors discussed and agreed wire was not in vessel and will review further.Additional information provided 03/21/2024: it was reported, "no serious harm.A fragment of the wire was left in the patient, but was fixed and did not need removed.".
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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaulation.
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 complaint of a damaged guidewire was confirmed.The product returned for evaluation was one guidewire.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.The returned product sample was evaluated and the guidewire was confirmed to be broken which allowed the outer coil wire to become unraveled.Microscopic examination of the fracture sites revealed the following: ¿ shearing of the wire at the break which was indicative of direct contact with a hard-edged instrument (such as an introducer needle) ¿ narrowing of the wire cross-section near the fracture site, which is a characteristic feature of a strong pull on the wire ¿ the weld tip of the wire was missing and could not be accounted for during the evaluation normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle.An examination of the wire structure revealed no potential damage/defect related to manufacture of the product.
Event or Problem Description
It was reported by the customer that attempt was made to place 3cg sherlock picc line in right basilic vessel.Vessel was accessed with blood return.Micropuncture wire inserted through access needle.Resistance was met and i immediately stopped advancing the wire.Tried to remove the wire and met resistance so stopped and tried to remove the wire and needle together and still could not remove wire.Needle was removed with wire left in place.Ir called to assess patient.Fluoroscopy was used and wire was shown to have looped and there was a knot at end.It was recommended to put dilator over wire to try to straighten out wire.The wire did start coming out and was pulled out by doctor together with the dilator.The wire was shredded and fluoro was taken and a small piece of the wire was retained in the arm.Doctors discussed and agreed wire was not in vessel and will review further.Additional information provided 03/21/2024: it was reported, "no serious harm.A fragment of the wire was left in the patient, but was fixed and did not need removed.".

• Brand Name: POWERPICC SOLO 4F SL MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER
• 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: 19028708
• Report Number: 3006260740-2024-01420
• Device Sequence Number: 6992063
• Product Code: LJS
• UDI-Device Identifier: 00801741154997
• UDI-Public: (01)00801741154997
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 1194108D3
• Device Lot Number: REHX3506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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: Required Intervention
• Patient Sex: Unknown