MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F NURSE FULL TRAY WITH M; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number	1295108
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
On (b)(6) 2016- per sales representative, user facility reported that upon insertion of the picc line the guidewire got caught in the tissue and came uncoiled.It was stated that the tip of the guidewire was lodged in the subcutaneous tissue and was removed in interventional radiology.There was no patient harm.The rn stated that she did not think it was a quality issue but a difficult tissue and anatomy issue.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F NURSE FULL TRAY WITH M
• 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: 5769067
• Report Number: 3006260740-2016-00315
• Device Sequence Number: 18959428
• Product Code: LJS
• UDI-Device Identifier: 00801741034596
• UDI-Public: (01)00801741034596
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/14/2016

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 Catalogue Number: 1295108
• 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: 07/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention