MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 FR. S/L POWERPICC - RADIOLOGY, STANDARD, 70 CM; PERCUTANEOUS, IMPLANTED, LONG TERM IV CATHETER

Model Number	3174155
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2017
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reav0980 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when the guidewire was passed after the puncture, there was resistance in the passage of the guidewire, and when the guidewire was removed, it was twisted, and there were no new pass conditions.No patient injury was reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 guidewire was confirmed, and the damage appears to be use related.It was reported that the guidewire met resistance during insertion and was noted to be twisted after it was removed.One 0.018¿ x 70cm guidewire was returned for investigation.Bends and kinks were observed in the distal 5.3cm of the coiled portion of the guidewire.A tactual investigation confirmed that the guiedwire was intact.The weld tip was not broken.The outside diameter (od) of the guidewire was measured with calipers and was found to be within specification.This type of damage can occur if the wire is forced against resistance or retracted through the introducer needle.One of the precautions in the ifu states, ¿if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ the ifu also states, ¿do not use excessive force when introducing guidewire.¿.
Event or Problem Description
It was reported that when the guidewire was passed after the puncture, there was resistance in the passage of the guidewire, and when the guidewire was removed, it was twisted, and there were no new pass conditions.No patient injury was reported.

• Brand Name: 4 FR. S/L POWERPICC - RADIOLOGY, STANDARD, 70 CM
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM IV CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6844575
• Report Number: 3006260740-2017-01537
• Device Sequence Number: 11143696
• Product Code: LJS
• UDI-Device Identifier: 00801741027611
• UDI-Public: (01)00801741027611
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2017

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: Other
• Device Expiration Date: 12/28/2019
• Device Model Number: 3174155
• Device Catalogue Number: 3174155
• Device Lot Number: REAV0980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1