MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY S/L (70 CM NITINOL GUIDEWIRE); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	10/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, patient admitted (b)(6) 2024 for osteo of her right toe.Patient was previous on 3rd floor in september, dc'd with picc line for home health antibiotic treatment.Upon admission this time, her arm with the picc line was swollen.Last night the md ordered the picc to be removed and the tip sent for cultures.When the picc was removed, the picc tubing was shorten than expected.The rn notified the md and it was verified via x-ray and us that part of the line remained in the patient's arm.She also has a dvt.Part of the picc that was removed was sent to lab for culture testing per md orders.The patient has orders to go to ir this morning to remove the retained portion.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 be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported, patient admitted (b)(6) 24 for osteo of her right toe.Patient was previous on 3rd floor in september, dc'd with picc line for home health antibiotic treatment.Upon admission this time, her arm with the picc line was swollen.Last night the md ordered the picc to be removed and the tip sent for cultures.When the picc was removed, the picc tubing was shorten than expected.The rn notified the md and it was verified via x-ray and us that part of the line remained in the patient's arm.She also has a dvt.Part of the picc that was removed was sent to lab for culture testing per md orders.The patient has orders to go to ir this morning to remove the retained portion.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 complaint of a catheter break was confirmed.The product returned for evaluation was one 4fr sl powerpicc solo catheter.Gross visual inspection of the returned catheter found that the catheter tubing had two complete breaks, one between the 3-4cm depth markers and another between the 7-8cm depth markers.The segment of tubing between the 4cm-7cm depth markers was not returned.Microscopic inspection of the fracture sites found that the break between the 3-4cm depth markers had striations on the fracture surface, indicating that the tubing had likely been intentionally cut by the clinician at this location.Inspection of the break site at 7-8cm found that the fracture surface was granular, the edge was rounded and the tubing cross-section had an elliptical shape.Additionally, a section of tubing adjacent to the break site had plastic deformation consistent with material buckling.These features are indicative of tensile stress and suggest that flexural fatigue may have contributed to the reported event.However, ultimately, there was not enough evidence to conclusively determine how the break occurred.Therefore, the root cause remains unknown.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY S/L (70 CM NITINOL GUIDEWIRE)
• 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: 20633985
• Report Number: 3006260740-2024-06498
• Device Sequence Number: 12634649
• Product Code: LJS
• UDI-Device Identifier: 00801741027789
• UDI-Public: (01)00801741027789
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/07/2025

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 Model Number: N/A
• Device Catalogue Number: 3194355
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/30/2025
• 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: Required Intervention
• Patient Sex: Unknown