MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER WITH SHERLOCK TIP LOCATION SYSTEM; 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	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reen1172 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the needle went into the vein find and when the guidewire advanced, the patient claimed to feel that.The guidewire seemed to loop and the nurse pulled back on the guidewire, encountering resistance when pulling back, but finally able to slowly pull out the guidewire; however, it was very clear that the wire was frayed, unravelling, and bent at the tip.
Event or Problem Description
It was reported that the needle went into the vein find and when the guidewire advanced, the patient claimed to feel that.The guidewire seemed to loop and the nurse pulled back on the guidewire, encountering resistance when pulling back, but finally able to slowly pull out the guidewire; however, it was very clear that the wire was frayed, unravelling, and bent at the tip.
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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a broken guidewire was confirmed.The product returned for evaluation was a guidewire within the packaging hoop.Residual material was seen within the coils of the wire.The coil wire was elongated, making the overall length of the guidewire 27.1¿.The inner core wire had broken approximately 0.5¿ proximal to the weld tip.It appeared that the inner core wire had broken which allowed the outer coil wire surrounding it to unravel.Microscopic examination revealed that the core wire was curved proximal and distal of break site.The break edges in the core wire were perpendicular to the axis of the wire and appeared straight and well defined.The outer diameter of the guidewire was measured near the proximal end and within the coil wire region.The outer diameters were within the device specifications.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.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.The product ifu cautions, ¿if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging of shearing the guidewire.¿ h3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK TIP LOCATION SYSTEM
• 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
• MDR Report Key: 11608847
• Report Number: 3006260740-2021-01102
• Device Sequence Number: 19807879
• Product Code: LJS
• UDI-Device Identifier: 00801741028618
• UDI-Public: (01)00801741028618
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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 Model Number: N/A
• Device Catalogue Number: 9194118
• Device Lot Number: REEN1172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other