MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET (; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Material Fragmentation (1261); Physical Resistance/Sticking (4012)

Patient Problems Thrombus (2101); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

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 of thrombus was inconclusive because no sample was returned to vad for evaluation.Based on the description of the reported event, possible contributing factors include catheter maintenance, patient physiology, and fibrin formation; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time and the reported event could not be confirmed as a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of recn1316 showed no other similar product complaint(s) from this lot number.Facility discarded.

Event Description

Per ms&s: nurse attempted to remove a picc and about 20cms came out and it became stuck.The patient is chronically ill and has had 3 picc lines in his right arm.An ultrasound revealed a 2 cm clot/dvt in the brachial vein around the picc.The picc is documented as being 41cms in length and there is 20cms external.They will leave the picc in place and use lovenox to dissolve the clot and remove at a later date.Ms&s: explained that the picc can get stuck in an stenosis or on a valve.Discussed groshong design.Suggested they get and arm ultrasound or x-ray to rule out a knot in the catheter or clot.Discussed applying heat and other measures to help the vessel dilate.On (b)(6) 2018 lovenox was used to dissolve the clot well enough to remove the line.Patient still remains on lovenox for further clot removal.Catheter was discarded after removal, no further patient complications at this time.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET (
• 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: heather murphy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225738
• MDR Report Key: 8055422
• MDR Text Key: 126719471
• Report Number: 3006260740-2018-03187
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741152610
• UDI-Public: (01)00801741152610
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/09/2018

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: N/A
• Device Catalogue Number: CK000827
• Device Lot Number: RECN1316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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): Required Intervention
• Patient Age: 17 YR