MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 FT CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F; LONG TERM INTRAVASCULAR CATHETER

Catalog Number	9295108FD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a knotted guidewire was confirmed; however, the cause was undetermined.The product returned for evaluation was one photograph the ends of two guidewires.The bottom wire was unremarkable.The top guidewire exhibited usage residues.A knot-like formation appeared visible near the end of the top wire.While what appeared to be a knot was visible near the end of the depicted wires, inspection of the submitted photograph was insufficient to identify the root cause.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
On (b)(6) 2016 - per (b)(6), a risk manager called to report a complaint regarding a powerpicc solo2.Contact stated that a nurse inserted the guidewire but it would not advance.She tried to remove it but stopped when resistance was met.Another nurse was called for assistance who then used a dilator to dilate the skin and was able to remove the guidewire.Nurse stated that the tip "looked like it was tied in a knot.".

• Brand Name: POWERPICC SOLO2 FT CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F
• Common Device Name: LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5668474
• Report Number: 3006260740-2016-00229
• Device Sequence Number: 18877006
• Product Code: LJS
• UDI-Device Identifier: 00801741035784
• UDI-Public: (01)00801741035784
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/29/2016

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 Catalogue Number: 9295108FD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2016
• Initial Report FDA Received Date: 05/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1