MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLE; 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)
Date of Event	12/04/2018
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 recu1663 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "during picc placement encountered problem with mst wire.Vessel accessed with needle, unable to thread wire, re-positioned needle attempted to thread wire met resistance again.Wire estimated to be just past the tip of the needle.I attempted to pull wire out, met resistance in pulling wire out.I had to pull the needle and wire out as a unit.The wire had frayed and i had to pull long string like wire the remaining way out of the patients arm.New mst kit used and vein was accessed without problems.".
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 frayed guidewire was confirmed and the cause was determined to be use related.The product returned for evaluation was 0.018" x 50cm nitinol guidewire.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.The returned product sample was evaluated and the guidewire was confirmed to be broken with the coil wire being unraveled.It appeared that the inner core wire had broken which allowed the outer coil wire surrounding it to unravel.Microscopic examination of the fracture sites revealed the following: ¿ shearing of the wire at the break which was indicative of direct contact with a hard-edged instrument (such as an introducer needle) ¿ narrowing of the wire cross-section near the fracture site, which is a characteristic feature of a strong pull on the wire ¿ the weld tip of the wire was missing and could not be accounted for during the evaluation 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 instruction for use (ifu) contains the following information which may be relevant to this type of event, "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.A lot history review (lhr) of recu1663 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "during picc placement encountered problem with mst wire.Vessel accessed with needle, unable to thread wire, re-positioned needle attempted to thread wire met resistance again.Wire estimated to be just past the tip of the needle.I attempted to pull wire out, met resistance in pulling wire out.I had to pull the needle and wire out as a unit.The wire had frayed and i had to pull long string like wire the remaining way out of the patients arm.New mst kit used and vein was accessed without problems.".

• Brand Name: POWERPICC SOLO2 FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLE
• 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: 8235787
• Report Number: 3006260740-2018-03843
• Device Sequence Number: 1947485
• Product Code: LJS
• UDI-Device Identifier: 00801741087509
• UDI-Public: (01)00801741087509
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 02/14/2019

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 Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: CK000361
• Device Lot Number: RECU1663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 105