MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 5F BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, "a 5 fr picc catheter was inserted, but when the guidewire was inserted, it didn't progress.When i tried to remove it to start the procedure again, it got tangled up "inside the patient's arm".In an attempt not to force the material, i used the technique of pulling the guidewire slightly, turning it from side to side.After a few minutes, with some difficulty, i managed to pull it out, but only part of it came out, broken and "frayed", the tip of the wire remained inserted in the patient, but it was possible to remove it by gently pulling the exposed part.It was not possible to separate the guide wire because it contained biological material.There was no damage, except that the patient remained without the catheter.The catheter wasn't even inserted." no other information was provided.
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.
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 broken guidewire is confirmed; however, the exact cause is unknown.Two photographs of a guidewire was returned for evaluation.An initial visual observation of the photographs showed a fractured guidewire with two distinct pieces.The longer complimentary fractured section appears to be an exposed core wire.While a fracture of the guidewire is observed in the photographs no details of the fracture can be discerned.There were no distinguishing features in the returned photographs of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported, "a 5 fr picc catheter was inserted, but when the guidewire was inserted, it didn't progress.When i tried to remove it to start the procedure again, it got tangled up "inside the patient's arm".In an attempt not to force the material, i used the technique of pulling the guidewire slightly, turning it from side to side.After a few minutes, with some difficulty, i managed to pull it out, but only part of it came out, broken and "frayed", the tip of the wire remained inserted in the patient, but it was possible to remove it by gently pulling the exposed part.It was not possible to separate the guide wire because it contained biological material.There was no damage, except that the patient remained without the catheter.The catheter wasn't even inserted." no other information was provided.Additional info received 12 march 2024 : there was no damage, except that the patient remained without the catheter.The catheter wasn't even inserted.The problem was with the guide wire.As there was some resistance, the nurse tried to reposition/remove the guide wire and in doing so, the guide wire ended up "unraveling/broken" and part of it remained in the patient.
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 a broken guidewire is confirmed; however, the exact cause is unknown.Two photographs of a guidewire was returned for evaluation.An initial visual observation of the photographs showed a fractured guidewire with two distinct pieces.The longer complimentary fractured section appears to be an exposed core wire.While a fracture of the guidewire is observed in the photographs no details of the fracture can be discerned.There were no distinguishing features in the returned photographs of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported, "a 5 fr picc catheter was inserted, but when the guidewire was inserted, it didn't progress.When i tried to remove it to start the procedure again, it got tangled up "inside the patient's arm".In an attempt not to force the material, i used the technique of pulling the guidewire slightly, turning it from side to side.After a few minutes, with some difficulty, i managed to pull it out, but only part of it came out, broken and "frayed", the tip of the wire remained inserted in the patient, but it was possible to remove it by gently pulling the exposed part.It was not possible to separate the guide wire because it contained biological material.There was no damage, except that the patient remained without the catheter.The catheter wasn't even inserted." no other information was provided.Additional info received 12 march 2024 : there was no damage, except that the patient remained without the catheter.The catheter wasn't even inserted.The problem was with the guide wire.As there was some resistance, the nurse tried to reposition/remove the guide wire and in doing so, the guide wire ended up "unraveling/broken" and part of it remained in the patient.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 5F BASIC TRAY
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19024025
• Report Number: 3006260740-2024-01414
• Device Sequence Number: 19838773
• Product Code: LJS
• UDI-Device Identifier: 00801741034633
• UDI-Public: (01)00801741034633
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2024

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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 1295118
• Device Lot Number: REGW1601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 05/06/2024; 07/11/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/09/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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