MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F MA; CATHETER,INTRAVASCULAR,THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reds4277 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that facility had a wire break.It was off of a 5 fr triple lumen.No other information provided at time of reporting.(b)(6) 2019: additional information from the facility stated, "we do not use 3cg; it was the magnet wire not the guidewire.Right arm basilic insertion of triple lumen picc line.Difficulty encountered around shoulder.Attempted supinated arm and insert.Attempted to flush and insert.Upon moving right arm toward head, line moved forward and appeared in the jugular.Attempted chin to right shoulder, attempted flush.Difficulty visualizing bullseye at this point, did not want to remove beyond shoulder, inserted- received blood return- flush, broke introducer- removed guidewire, removed magnet wire.Upon inspecting tip of magnet wire, noted to be broken.Remove picc line, assessed patient, chest xray ordered.Chest was clear.Xrayed picc to note a fractured piece of wire inside.".
Event or Problem Description
It was reported that facility had a wire break.It was off of a 5 fr triple lumen.No other information provided at time of reporting.(b)(6) 2019: additional information from the facility stated, "we do not use 3cg; it was the magnet wire not the guidewire.Right arm basilic insertion of triple lumen picc line.Difficulty encountered around shoulder.Attempted supinated arm and insert.Attempted to flush and insert.Upon moving right arm toward head, line moved forward and appeared in the jugular.Attempted chin to right shoulder, attempted flush.Difficulty visualizing bullseye at this point, did not want to remove beyond shoulder, inserted- received blood return- flush, broke introducer- removed guidewire, removed magnet wire.Upon inspecting tip of magnet wire, noted to be broken.Remove picc line, assessed patient, chest xray ordered.Chest was clear.Xrayed picc to note a fractured piece of wire inside.".
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken stylet was confirmed but the exact cause is unknown.One 5 fr tl powerpicc catheter solo with the tls stylet t lock assembly was returned for investigation.The stylet was returned outside of the catheter.The distal 6 cm of the stylet was observed to contain multiple kinks and be curled.Microscopic observation of the distal end of the stylet revealed a complete break.The polyimide tubing break surface was observed to be uneven and compressed.The event description indicates that difficult advancement was experienced around the shoulder which suggest advancement against resistance may have been a contributing factor.The stylet was cut proximal to the kinked section in order to measure the polyimide tubing wall thickness.The wall thickness was found to be within manufacturing specification.Since the tls stylet was observed to be kinked and broken, the complaint is confirmed.A lot history review (lhr) of reds4277 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SOLO2 HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F MA
• 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: 9256026
• Report Number: 3006260740-2019-03377
• Device Sequence Number: 11276470
• Product Code: LJS
• UDI-Device Identifier: 00801741035906
• UDI-Public: (01)00801741035906
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: 9395108QD
• Device Lot Number: REDS4277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1