MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135 CM GUIDEWIRE); 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	06/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of recw0499 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by doctor that kinked wire was observed in picc set before use.No other information provided.
Event or Problem Description
It was reported by doctor that kinked wire was observed in picc set before use.No other information provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kinked guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 135cm ir guidewire.The sample was received loaded backward in its plastic hoop.Usage residues were observed throughout the coil/core region of the wire.The weld tip was intact.A kink was observed approximately midway along the length of the coil region.Curved shape memory was observed leading into the kink site.Tactile inspection of the sample confirmed that the core wire was intact.Microscopic inspection of the sample confirmed biological residue throughout the coil region.The kink and curved shape memory were consistent with attempted insertion against resistance.Such resistance can occur if insertion is attempted into tissue or through a tortuous path.The biological residue on the wire suggested that resistance was encountered during attempted device use.

• Brand Name: POWERPICC 6F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (135 CM 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: 8828830
• Report Number: 3006260740-2019-02202
• Device Sequence Number: 14141893
• Product Code: LJS
• UDI-Device Identifier: 00801741028007
• UDI-Public: (01)00801741028007
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K050931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 3276135
• Device Lot Number: RECW0499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 07/27/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1