MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO 5 FR DL WITH SHERLOCK 3CG STYLET; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	1295118
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/26/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebp1486 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that on (b)(6) 2017, the picc was inserted on (b)(6) 2017, using sherlock tcs.The tip position was confirmed using the sherlock device with a small p wave elevation only and no xray was required.On (b)(6) 2017, an xray was ordered for a possible non-related issue and the tip of the picc was found to be in the ivc.The healthcare professional ordered to pull back the picc by 8cm.
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 that the tip of the picc was in the ivc was confirmed from a medical imaging report, but the exact cause of the reported event was not identified.Three images were provided for investigation.The first image showed two separate waveforms that were labeled external and intravascular.The date on the page was (b)(6) 2017.The exit site marking was listed as 3cm and the trim length was 44cm.What appeared to be a p-wave, consistent with the image in the ifu, was present on the intravascular scan.The second image, dated (b)(6) 2017 14:16, contained a radiographic image accompanied by a medical imaging report.The reported stated, ¿right-sided picc line tip is likely within the ivc and is should be retracted by approximately 8 cm.¿ the third image, dated (b)(6) 2017 12:29, contained a radiographic image accompanied by a medical imaging report.The reported stated, ¿comparison is made with previous chest radiograph from (b)(6) 2017 (16:19 hrs).Interval alteration in position of the right-sided picc with its tip now likely within the upper svc (previous chest radiograph demonstrates picc crossing the midline and likely within the left brachiocephalic vein.) it was unknown if the picc malposition occurred during or after the placement procedure.It was unknown if the picc securement and dressing technique or any complications associated with the clinical setting were factors in the reported event.It was unknown if the stylet was in the correct position within the catheter.The ifu states, ¿prior to insertion, ensure that the stylet tip is contained inside and within the catheter but not more than 1 cm from the trimmed end of the catheter.¿.
Event or Problem Description
It was reported that on (b)(6) 2017, the picc was inserted on (b)(6) 2017, using sherlock tcs.The tip position was confirmed using the sherlock device with a small p wave elevation only and no xray was required.On (b)(6) 2017, an xray was ordered for a possible non-related issue and the tip of the picc was found to be in the ivc.The healthcare professional ordered to pull back the picc by 8cm.

• Brand Name: POWERPICC SOLO 5 FR DL WITH SHERLOCK 3CG STYLET
• 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: 6900846
• Report Number: 3006260740-2017-01723
• Device Sequence Number: 13652043
• Product Code: LJS
• UDI-Device Identifier: 00801741034633
• UDI-Public: (01)00801741034633
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: Health Professional
• Device Model Number: 1295118
• Device Catalogue Number: 1295118
• Device Lot Number: REBP1486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1