MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 FR SL POWERPICC SOLO CATHETER 70CM SS; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	3194155
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/27/2015
Type of Reportable Event	Serious Injury
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, at this time, for evaluation.Lot history review (lhr) of rezh1687 showed no other similar product complaint(s) from these lot numbers.Device not returned, at this time.
Event or Problem Description
It was reported that during the installation of a picc line, the terumo guidewire apparently broke off in the patient's arm.The remaining piece was a few mm long.They reportedly were unable to remove the left over piece.Checking the position of ec in the next scan to see whether migration occured.The facility reports it was not the terumo glidewire that frayed but the guidewire included in the kit.It was during needle puncture, on introduction of the manufaturers guidewire, that it became stuck in the axillary region.Being unable to advance the guidewire, "we decided to take it back out again from the puncture needle.It was at this point that it frayed.A small piece of metal from the guidewire remained in the patient.Subsequently, we took a terumo glidewire fitted with a smoother, curved tip, and were finally successful in putting in our picc-line".A small piece of the guidewire remains in the patient.Chest x-ray on (b)(6) 2015 showed that there had been no migration of this foreign body.

• Brand Name: 4 FR SL POWERPICC SOLO CATHETER 70CM SS
• 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: 5457465
• Report Number: 3006260740-2016-00054
• Device Sequence Number: 325269
• Product Code: LJS
• UDI-Device Identifier: 00801741027765
• UDI-Public: (01)00801741027765(17)170228(10)REZH1687
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 3194155
• Device Lot Number: REZH1687
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1