MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER 5F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(70CM); PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	3385355Q
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an inability to get blood return, difficulty flushing, and a leak was confirmed, and the damage appears related to use of the device.One 5 fr triple lumen (t/l) powerpicc was returned for investigation.A visual observation of the returned sample revealed evidence of use.The non-power extension legs and bifurcation were discolored.A breach, which exposed all three lumens, was observed at the 1cm depth mark.The breach consisted of splits in various directions.Residue was found on the external surface of the catheter on each side of the breach in the tubing.The catheter was observed to be kinked in five locations between the 3cm and 7cm depth marks.The t/l tubing was also kinked at the 9cm and 10cm depth marks.The product ifu states, ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ the t/l tubing was slightly flattened/compressed between the 10 and 44cm depth marks.The catheter extended 2mm distal to the 54cm depth mark.A microscopic examination of the cross section at the distal end of the t/l tubing revealed a glossy and striated surface, which is indicative of a cut made with a sharp instrument.In contrast, the surface of the multiple splits at the 1cm depth mark exhibited a jagged and rough surface, which is indicative of a tear.A functional test of the catheter revealed that fluid leaked from each lumen at the breach, which was located at the 1cm depth mark.The section of tubing distal to the breach was occluded.Blood residue was expelled from the catheter.The kinking and occlusion in the lumens may have contributed to the reported inability to withdraw blood and flush.The breach at the 1cm depth mark could also be the result of kinking and/or flushing against the occlusion.The product ifu states, ¿warning: failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.Use only lumens marked ¿power injectable¿ for power injection of contrast media.Warning: use of lumens not marked ¿power injectable¿ for power injection of contrast media may cause failure of the catheter.¿ suggested catheter maintenance is provided in the ifu to prevent occlusions in the lumens.It states, ¿flush each lumen of the catheter with 10ml of saline every 12 hours or after each use.In addition, lock each lumen of the catheter with heparinized saline.Usually one ml per lumen is adequate.Catheters that present resistance to flushing and aspiration may be partially or completely occluded.Do not flush against resistance.If the lumen will neither flush nor aspirate and it has been determined that the catheter is occluded with blood, a declotting procedure per institution protocol may be appropriate.¿ a lot history review (lhr) of reap1910 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales representative, nurse reported that their vascular access team was called to consult on a patient regarding difficulty with piccs.They could not get blood return and had difficulty flushing.Team checked for mechanical obstruction, flushed the picc, and noticed saline leaking from the insertion site.The team retracted the picc a little more, flushed twice and was able to identify a kink and puncture to catheter.Picc was removed at the time this was identified.No patient harm reported.

• Brand Name: POWERPICC HF CATHETER 5F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(70CM)
• 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: 5765561
• Report Number: 3006260740-2016-00310
• Device Sequence Number: 16475291
• Product Code: LJS
• UDI-Device Identifier: 00801741028205
• UDI-Public: (01)00801741028205(17)180928(10)REAP1910
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/10/2016

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: 09/28/2018
• Device Catalogue Number: 3385355Q
• Device Lot Number: REAP1910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2016
• Initial Report FDA Received Date: 07/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1