MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER WITH SHERLOCK TIP LOCATION SYSTEM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recx2141 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guide wire broke during insertion of a picc.It was stated angio had to "fish out" the broken end.It was reported the placer could not get the wire to go down svc.It had coiled back on itself.Sent to invasive radiology to fix.
Event or Problem Description
It was reported that the guide wire broke during insertion of a picc.It was stated angio had to "fish out" the broken end.It was reported the placer could not get the wire to go down svc.It had coiled back on itself.Sent to invasive radiology to fix.
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 stylet break is confirmed but the exact cause remains unknown.One 50cm guidewire and one tls stylet t lock assembly were returned for investigation.The distal 11 cm of the stylet was observed to be coiled and kinked.Dried, red use residue was present throughout the stylet.No apparent kinks or damage was observed on the guidewire.Microscopic observation of the distal end of the stylet revealed a complete break in the tubing.The distal break site was compressed likely due to kinking.The tubing was cut proximal to the distal end.The wall thickness of the polyimide tubing was measured and found to be within specification.Based on the condition of the returned sample, possible contributing factors include advancement against resistance and patient anatomy.The event description indicates that a difficult advancement was experienced which likely contributed to the reported event.Since evidence of a complete break was observed on the tls stylet, the complaint is confirmed.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of recx2141 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER WITH SHERLOCK TIP LOCATION SYSTEM
• 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: 9173527
• Report Number: 3006260740-2019-02971
• Device Sequence Number: 2413624
• Product Code: LJS
• UDI-Device Identifier: 00801741035685
• UDI-Public: (01)00801741035685
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K063240
• 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): 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9275108
• Device Lot Number: RECX2141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 10/29/2019
• 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: Required Intervention