MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135CM GUIDEWIRE); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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 damaged guidewire is confirmed and was determined to be use related.One 0.018 in.Guidewire in a plastic hoop was returned for evaluation.An initial visual observation showed use residue on the returned sample.The coiled portion of the guidewire was observed to be slightly bent and curved, and a kink was observed between two coils about 1.5 cm proximal to the distal tip.No breaks were observed in the guidewire during tactile evaluation.A microscopic observation revealed the weld tip was present and intact.The core wire could be seen between the kink in the coiled wire.The use residue on the returned guidewire as well as the location and characteristics of the kink in the guidewire suggest the guidewire was most-likely damaged during use due to advancement against resistance, retraction of the guidewire against the bevel of the introducer needle, and/or patient anatomy.A lot history review (lhr) of recw1325 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The guidewire was found bent during insertion at x-ray in mid (b)(6) 2020.(b)(6) 2020- returned guidewire is kinked.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135CM GUIDEWIRE)
• 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: 10035607
• Report Number: 3006260740-2020-01697
• Device Sequence Number: 11509800
• Product Code: LJS
• UDI-Device Identifier: 00801741028106
• UDI-Public: (01)00801741028106
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Report Date (Section B): 05/07/2020

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: 03/24/2020
• Device Model Number: N/A
• Device Catalogue Number: 3295135
• Device Lot Number: RECW1325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1