MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD MYPICC KIT; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	CK000434
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2016
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 broken guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one nitinol guidewire.Usage residues were observed throughout the distal end of the sample.The inner core wire was broken.The outer coil wire was elongated and broken.The weld tip was completely detached and was not returned for evaluation.Attempt to insert a non-damaged region the sample through a similar non-complainant needle were successful and unremarkable.Microscopic inspection of the breaks in the inner core wire and outer coil wire revealed material necking in the vicinities of the breaks.The break edges exhibited dully granular surfaces.The break surfaces also exhibited small regions of increased luster.The material necking and granular break surface were typical of damage caused by tensile stress.The regions of increased luster were typical of contact with a hard object such as the introducer needle bevel.It appeared that an attempt was made to withdraw the wire against the needle bevel.The wire became stuck and subsequent pulling caused the observed breaks in the wire.The product ifu states ¿if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ a lot history review (lhr) of 15hb3802 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility contact reported that a guidewire met resistance when inserting.The needle was removed and the wire resisted removal.The wire was taken out after increased pressure was applied; however, it began to unravel during removal.X-rays obtained after the guidewire was removed noted a residual foreign body in the arm above the placement site.The device was not successfully implanted in the patient's right arm.A new picc line was successfully placed in the left arm without complications.

• Brand Name: BARD MYPICC KIT
• 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: 5405795
• Report Number: 3006260740-2016-00016
• Device Sequence Number: 13551102
• Product Code: LJS
• UDI-Device Identifier: 00801741102875
• UDI-Public: (01)00801741102875(17)161231(10)15HB3802
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Initial Reporter Occupation: Health Professional
• Report Date (Section B): 01/10/2016

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: 12/31/2016
• Device Catalogue Number: CK000434
• Device Lot Number: 15HB3802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 69