MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F MAXIMAL BARRIER TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 1194108D

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Loss of Vision (2139)

Event Type  Injury  

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 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 an arterial placement could not be verified with the evidence provided for investigation.One photo of an ecg printout was provided for investigation.The printout showed both the external and intravascular waveforms.That the picc tip was residing in the thoracic aorta was inconclusive.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.The product ifu states, ¿the powerpicc solo2 ® catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allows for central venous pressure monitoring.¿ one of the placement warnings in the ifu states, ¿if the artery is entered, withdraw the needle and apply manual pressure for several minutes.¿ during venipuncture, the ifu warns, ¿if the artery is entered, withdraw the needle or safety iv catheter and apply manual pressure for several minutes.¿ the picc placement ifu with sherlock 3cg stylet provides the following instructions.¿the sherlock 3cg* tps stylet, sherlock 3cg* tcs system, and the site~rite* ultrasound system, include a comprehensive, integrated set of picc placement tools such as vein location, lumen size visualization, needle guided vein access, catheter tip orientation, catheter tip depth, catheter tip placement using ecg, and ecg placement documentation.¿ ¿select a vein based on patient assessment and pre-scan.Recommended veins are basilic, cephalic, and brachial veins.¿ ¿7.Access vein a.Perform ultrasound and locate vessel.Follow ultrasound system instructions for use.Perform microintroduction.Follow catheter instructions for use regarding microintroduction technique.Secure guidewire.¿ a lot history review (lhr) of recq1422 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported picc was placed in a brachial vein using sherlock 3cg to confirm placement.Soon after insertion, the patient lost vision.The patient developed pain in her arm and became agitated.Cxr, doppler and blood gasses were done and showed picc was arterial with the tip residing in the thoracic aorta.These weren¿t done until (b)(6) when the picc was then removed.On (b)(6) 2018-facility reported that patient was septic unknown if vision loss was related to picc placement or antibiotic administration.Picc removed patient discharged.Vision is improving.Reviewed clinical signs or arterial placement with picc leader.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 4F MAXIMAL BARRIER TRAY
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7614450
• MDR Text Key: 111525879
• Report Number: 3006260740-2018-01432
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034510
• UDI-Public: (01)00801741034510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1194108D
• Device Catalogue Number: 1194108D
• Device Lot Number: RECQ1422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR