MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/BIOPATCH & PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 recv3906 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that while inserting the picc the guidewire unraveled at the tip.They were able to remove the entire wire.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken guidewire is confirmed and was determined to be use related.One 0.018 in.Nitinol guidewire was returned for evaluation.An initial visual observation showed the coiled wire of the guidewire was severely unraveled and the core wire was broken.Use residue was observed throughout the returned sample.A microscopic observation revealed the weld tip was missing and broken off of the coiled wire.The break site of the coiled wire was observed to be straight and the surface of the break was observed to be flat with a granular texture.The break site of the core wire was observed to be tapered and the surface of the break was observed to be angled with a granular texture.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of the wire and/or cause the wire to become stuck within the needle.The product ifu states: ¿if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ an examination of the wire structure revealed no potential damage/defect related to manufacture of the product.
Event or Problem Description
It was reported that while inserting the picc the guidewire unraveled at the tip.They were able to remove the entire wire.

• Brand Name: POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/BIOPATCH & PROBE COVER
• 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: 8818895
• Report Number: 3006260740-2019-02139
• Device Sequence Number: 2839228
• Product Code: LJS
• UDI-Device Identifier: 00801741155116
• UDI-Public: (01)00801741155116
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: S1295108FD4
• Device Lot Number: RECV3906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/27/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1