MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 4F MAXIMAL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	9274108D
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2018
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recp1588 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was placed on (b)(6) 2018 "svc - cavoatrial junction." the picc was "cut at 32 cm, but inserted at 33 cm, plus one - up to the hub." on (b)(6) 2018 the catheter cracked at the bifurcation during an infusion, and it started to leak.It was stated the dressing was not adhering well to the skin; the sides of the dressing had begun to rise up.This crack/leak occurred on the day the patient was scheduled to be discharged and have the picc removed.She successfully completed her chemo treatment; the leak caused no harm or delay in care.It was also noted that the picc was constantly used for infusion, by at least one lumen, during the entire length of her treatment.
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 a leaking catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 4fr d/l powerpicc sv catheter.Usage residues were observed throughout the sample.A longitudinally aligned split was observed just distal of the molded joint.An attempt to infuse water through the sample using a 12ml syringe revealed both lumens to be patent to infusion; however, when flushing the red-luered lumen, a leak was observed emanating from the aforementioned split site.Tactile inspection of the sample revealed material weakness in the vicinity of the split.The catheter kinked and twisted preferentially at the leak site during manual manipulation.Microscopic inspection of the split revealed an irregular granular fracture surface.The fracture edges curved inward slightly.The fracture features and material weakness were consistent with damage caused by repetitive twisting/kinking of the indwelling catheter.The location of the damage suggested that catheter securement/access technique may have contributed.A lot history review (lhr) of recp1588 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was placed on (b)(6) 2018 "svc - cavoatrial junction." the picc was "cut at 32 cm, but inserted at 33 cm, plus one - up to the hub." on (b)(6) 2018 the catheter cracked at the bifurcation during an infusion, and it started to leak.It was stated the dressing was not adhering well to the skin; the sides of the dressing had begun to rise up.This crack/leak occurred on the day the patient was scheduled to be discharged and have the picc removed.She successfully completed her chemo treatment; the leak caused no harm or delay in care.It was also noted that the picc was constantly used for infusion, by at least one lumen, during the entire length of her treatment.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 4F MAXIMAL
• 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: 7584501
• Report Number: 3006260740-2018-01313
• Device Sequence Number: 19257100
• Product Code: LJS
• UDI-Device Identifier: 00801741035678
• UDI-Public: (01)00801741035678
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: 9274108D
• Device Catalogue Number: 9274108D
• Device Lot Number: RECP1588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 53