MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER 5F FULL TRAY (TRIPLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redv2044showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redv2044) have been reported from the same facility.
Event or Problem Description
It was reported: "all 3 lumens with continuous infusions post-insertion"."8/20,@ 1900, gray and red lumens occluded; alteplase administered; patency restored to red lumen after 2 hour dwell, gray lumen remained occluded." "8/20 @ 2300, second dose of alteplase administered to gray lumen" "8/21 @ 0200, white lumen occluded, alteplase administered, patency restored" "8/21 @ 0300, gray lumen occluded, alteplase administered; 0500, gray lumen still occluded, provider notified" "8/21 @ 2100, white lumen occluded, alteplase administered; patency restored" "placement info: "5 fr triple lumen provena powerpicc placed in the right upper arm, brachial vein.12 cm external length; securacath in place".
Event or Problem Description
It was reported: "all 3 lumens with continuous infusions post-insertion" "(b)(6),@ 1900, gray and red lumens occluded; alteplase administered; patency restored to red lumen after 2 hour dwell, gray lumen remained occluded." "(b)(6) @ 2300, second dose of alteplase administered to gray lumen," "(b)(6) @ 0200, white lumen occluded, alteplase administered, patency restored," "(b)(6) @ 0300, gray lumen occluded, alteplase administered; 0500, gray lumen still occluded, provider notified," "(b)(6) @ 2100, white lumen occluded, alteplase administered; patency restored." "placement info: "5 fr triple lumen provena powerpicc placed in the right upper arm, brachial vein.12 cm external length; securacath in place.".
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.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 an occluded and leaking catheter was confirmed.The product returned for evaluation was one 5fr t/l powerpicc catheter.Usage residues were observed throughout the sample.A longitudinally aligned split was observed at the 18cm depth marking.Microscopic inspection of the split revealed a granular fracture surface.The split edges exhibited deformation and discoloration.An attempt to infuse water through the sample using a 12ml syringe revealed all three lumens to be patent to infusion; however, when flushing the grey-luered lumen, a leak was observed emanating from the site of the split.Some resistance was encountered when flushing the sample, suggesting a partial blood product occlusion.The fracture features were consistent with burst damage secondary to over-pressurization.Such damage can occur when attempting to flush an occluded catheter.The partial occlusions observed support these observations and appeared to be caused by accumulation of blood product residues.This suggests that catheter maintenance may have contributed.A lot history review (lhr) of redv2044showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redv2044) have been reported from the same facility.

• Brand Name: POWERPICC HF CATHETER 5F FULL TRAY (TRIPLE-LUMEN)
• 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: 10583405
• Report Number: 3006260740-2020-03356
• Device Sequence Number: 2627950
• Product Code: LJS
• UDI-Device Identifier: 00801741028168
• UDI-Public: (01)00801741028168
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

1 Device 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: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 3385108Q
• Device Lot Number: REDV2044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No