MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET M; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 damaged stylet was confirmed and the damage appeared to be associated with use.One 3cg stylet was returned for investigation.Most of the stylet wire had been retracted through the t-lock extension set.A 3.0 cm section of polyimide tubing extended from the funnel that was attached to the t-lock extension set.A section of the wire that had been pulled through the extension set was coiled and had been taped to the extension set before it was returned for investigation.The conductive epoxy at the distal tip of the stylet appeared to be incomplete.The length of the conduction epoxy was below the minimum specification limit.A microscopic observation of the distal tip of the stylet revealed the distal end of a magnet.It appeared that the polyimide tubing had been cut, which may have been a factor in the reported intermittent waveform.It is possible that the stylet had been inadvertently trimmed when the catheter was cut to length.The stylet needs to be well behind the point the catheter is to be cut.The red hang tag on the stylet warns against cutting the stylet.No damage associated with the manufacturing process was observed on the returned sample.A lot history review (lhr) of redz1811 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported preprocedure, calibrated sherlock, intravascular baseline present, after access gained, calibrated sherlock, intravascular baseline present, inserted picc into vein via introducer, intravascular waveform disappeared from screen, positioned picc via sherlock technology, then adjusted baseline waveform app to bring intravascular waveform back onto the screen, unable to return intravascular waveform to the screen, checked connections, all connected.Removed wire to confirm with cxr, when wire removed from pt vein, intravascular baseline reappeared, readvanced wire into picc, to confirm tip placement, waveform disappeared from screen, wire removed and cxr obtained.Delay of use of picc noted, as pt had to wait for cxr.Additional information received 06/26/2020: placement info: waveform disappeared from the screen, would not reappear or be adjusted with baseline adjustment app, returned to view when wire removed from picc, baseline was present on preprocedure calibration., all connections checked, line flushed with saline.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET M
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10405214
• Report Number: 3006260740-2020-02926
• Device Sequence Number: 14201106
• Product Code: LJS
• UDI-Device Identifier: 00801741096273
• UDI-Public: (01)00801741096273
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/13/2020

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: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: CK000408
• Device Lot Number: REDZ1811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR