MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN) (135 CM NITINOL G; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3194335
Health Effect - Clinical Code	Palpitations (2467)
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 device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) of rebz1819 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a nurse called into the ms&s helpline.Nurse states that her patient got powerpicc solo inserted on 5/1 and she states when the patient cross her arms together she experiences palpitations and they go away with the uncrossing of the arms.She is asking if that is normal.Response by ms&s: informed that nurse that she should contact her physician and ask about performing a chest x-ray in the position where the palpitations occur.Ms&s informed that the picc tip does change positions with certain movements and position changes.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) of rebz1819 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a nurse called into the ms&s helpline.Nurse states that her patient got powerpicc solo inserted on (b)(6) and she states when the patient cross her arms together she experiences palpitations and they go away with the uncrossing of the arms.She is asking if that is normal.Response by ms&s: informed that nurse that she should contact her physician and ask about performing a chest x-ray in the position where the palpitations occur.Ms&s informed that the picc tip does change positions with certain movements and position changes.(b)(6) 2018-the patient was sent to emergency room as a precaution.U/s showed picc placement was correct and all other indications pointing to picc causing the issues were eliminated.It has since been decided that the patient was likely having anxiety issues as the problem has not persisted.

• Brand Name: POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY (SINGLE-LUMEN) (135 CM NITINOL G
• 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: 7539190
• Report Number: 3006260740-2018-01053
• Device Sequence Number: 1862303
• Product Code: LJS
• UDI-Device Identifier: 00801741027772
• UDI-Public: (01)00801741027772
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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: 3194335
• Device Catalogue Number: 3194335
• Device Lot Number: REBZ1819
• Was Device Available for Evaluation?: No
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1