MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1395108D3
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kink in the stylet in the returned 3cg stylet was confirmed but the cause is unknown.A kink in the solid stylet wire was found 0.2¿ proximal of the t-lock assembly.A single kink was also present in the magnetic region of the stylet.The kink was located 0.42¿ from the distal tip of the stylet.Microscopic examination confirmed that they stylet was intact with the distal epoxy tip present.No breaks or fractures were seen within the magnets.The kink in the stylet had occurred between the 17th and 18th magnets, as counted from the proximal end of the device.The polyimide tubing was cut by the investigator, distal of the break site, to allow for dimensional analysis of the tubing.The outer and inner diameters were measured and met the device specifications.The exact cause of the kink in the stylet could not be determined from the returned sample.Possible contributing factors could include advancing or retracting the stylet against resistance, extension of the stylet tip past the trimmed end of the catheter, and/or advancing the catheter/stylet through a tortuous path.A lot history review (lhr) of reez1056 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "bent wire.Successful insertion but wire bent upon removal." on (b)(6) 2021: the returned device was found kinked.

• Brand Name: POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER
• 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: 12008882
• Report Number: 3006260740-2021-02310
• Device Sequence Number: 3304210
• Product Code: LJS
• UDI-Device Identifier: 00801741155024
• UDI-Public: (01)00801741155024
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2021

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: S1395108D3
• Device Catalogue Number: S1395108D3
• Device Lot Number: REEZ1056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/16/2021
• 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