MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during procedure, noticed that the picc guidewire curled up upon checking thru fluroscopy scan as patient was complaining of pain.Tried to take out the guidewire but it was stuck at the puncture needle.Have to take out guidewire together with puncture needle.Changed or opened another picc set.No problem with the new picc set.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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported that, during procedure, noticed that the picc guidewire curled up upon checking thru fluroscopy scan as patient was complaining of pain.Tried to take out the guidewire but it was stuck at the puncture needle.Have to take out guidewire together with puncture needle.Changed or opened another picc set.No problem with the new picc set.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.Based on a review of applicable information, the following was concluded: the complaint of a damaged guidewire is confirmed and was determined to be use related.One 0.018 in.X 135 cm guidewire was returned for evaluation.An initial visual observation showed use residue on the returned sample.The core wire of the guidewire was found to be broken and the coiled wire was observed to be unraveled.The distal end of the coiled wire was observed to not be unraveled and a relatively large amount of biological residue was observed at the proximal end of this section of the coiled wire.A microscopic observation revealed the break site of the core wire was tapered and mostly flat with a granular surface texture.The weld tip of the guidewire was observed to present and attached to the coiled wire.The characteristics observed on the returned guidewire are indicative of a tensile failure caused by excessive pulling forces on the guidewire.An examination of the wire structure revealed no potential damage/defect related to manufacture of the product.As a note, 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.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN)
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17839789
• Report Number: 3006260740-2023-04358
• Device Sequence Number: 12626802
• Product Code: LJS
• UDI-Device Identifier: 00801741028007
• UDI-Public: (01)00801741028007
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K050931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 3276135
• Device Lot Number: REFS2652
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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