MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER, 5F TL HF 3CG; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	CK000291B
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The following were reviewed as part of this investigation: patient severity, trend 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 damaged catheter stiffening stylet was confirmed and the cause appeared to be use-related.The product returned for evaluation was one tls 3cg stylet.Usage residues were observed throughout the sample.Multiple bends and kinks were observed along the length of the stylet wire.The sample was received in two segments which shared a complete break near the distal end of the stylet.The stylet wire protruded from the polyimide tubing at the distal fragment break site.Microscopic inspection of the wire revealed a granular break surface.Material necking was observed in the vicinity of the break.Microscopic inspection of break in the polyimide tubing revealed material buckling and deformation.The abundant kinking and break site deformation and buckling of the polyimide tubing was typical of damage caused by sample manipulation.The wire break features were consistent with failure under tensile (pulling) stress.The product ifu states ¿never use force to remove the stylet.¿ a lot history review (lhr) of rebn0973 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that the nurse was experiencing difficulty placing a picc in the patient.The nurse removed the guidewire and was cleaning the blood clot off of the end of the wire and the wire broke off in her hand.No patient injury was reported.

• Brand Name: POWERPICC SOLO CATHETER, 5F TL HF 3CG
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6489882
• Report Number: 3006260740-2017-00405
• Device Sequence Number: 1170130
• Product Code: LJS
• UDI-Device Identifier: 00801741132087
• UDI-Public: (01)00801741132087(17)171231(10)REBN0973
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2017

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: 12/31/2017
• Device Catalogue Number: CK000291B
• Device Lot Number: REBN0973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2017
• Initial Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1