MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F MAX BARRIER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	M120080
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of reby0639 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guidewire was found to be kinked approximately 2 inches from the tip, despite the inserter properly following all procedures and ifu direction.The inserter stated that ¿there was no resistance upon insertion of catheter or removal of wire during the procedure.The catheter was trimmed per usual routine and the guidewire was reinserted post saline flush per manufacturer instructions for use.Guidewire was bent on the rubber end cap for securement per ifu.The procedure was per normal routine and there were no concerns issues (with the catheter) warranting further investigation.Inserter stated that the sherlock symbol (lollipop) was spotty on the screen and there was no ecg waveform.X-ray was required to confirm placement.Successful placement of the picc with no adverse effects to the patient noted.¿.
Additional 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 a damaged stylet is confirmed and was determined to be use related.One tls ecg stylet was returned for evaluation.An initial visual observation showed a severe bend and partial break in the stylet approximately 5.2 cm proximal to the distal end of the stylet.Blood residue was observed on the stylet.A microscopic observation revealed the break surfaces of the stylet were rough but mostly even.The core wire was observed to be tapered at the break sites and the break surfaces were observed to be flat and granular in texture.The outer tubing of the stylet at the break site was observed to be tapered and plastically deformed.The tapering and plastic deformation observed at the break sites of the stylet are evidence of tensile failure due to excessive tensile and/or bending forces during handling, insertion, or withdrawal of the stylet.A lot history review (lhr) of reby0639 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guidewire was found to be kinked approximately 2 inches from the tip, despite the inserter properly following all procedures and ifu direction.The inserter stated that ¿there was no resistance upon insertion of catheter or removal of wire during the procedure.The catheter was trimmed per usual routine and the guidewire was reinserted post saline flush per manufacturer instructions for use.Guidewire was bent on the rubber end cap for securement per ifu.The procedure was per normal routine and there were no concerns issues (with the catheter) warranting further investigation.Inserter stated that the sherlock symbol (lollipop) was spotty on the screen and there was no ecg waveform.X-ray was required to confirm placement.Successful placement of the picc with no adverse effects to the patient noted.¿ no patient injury reported.

• Brand Name: POWERPICC HF CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F MAX BARRIER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7345643
• Report Number: 3006260740-2018-00450
• Device Sequence Number: 48477
• Product Code: LJS
• UDI-Device Identifier: 00801741075315
• UDI-Public: (01)00801741075315
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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: M120080
• Device Catalogue Number: 1385108QD
• Device Lot Number: REBY0639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1