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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2018
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 evaluate.Results are expected soon.A lot history review (lhr) of recs1790 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after unsuccessful attempts to position catheter in the svc, the catheter was retracted and became resistant.Repositioning of patient arm allowed removal of the catheter in its entirety, however, during removal of the wire, noticed the distal portion was almost severed/sheared off.Md was notified and xrays performed.There was no evidence of retained foreign bodies.
Additional Manufacturer Narrative
H11:section a through f - 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 evaluate.Results are expected soon.A lot history review (lhr) of recs1790 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after unsuccessful attempts to position catheter in the svc, the catheter was retracted and became resistant.Repositioning of patient arm allowed removal of the catheter in its entirety, however, during removal of the wire, noticed the distal portion was almost severed/sheared off.Md was notified and xrays performed.There was no evidence of retained foreign bodies.
Event or Problem Description
It was reported that after unsuccessful attempts to position catheter in the svc, the catheter was retracted and became resistant.Repositioning of patient arm allowed removal of the catheter in its entirety, however, during removal of the wire, noticed the distal portion was almost severed/sheared off.Md was notified and xrays performed.There was no evidence of retained foreign bodies.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 was confirmed.The product returned for evaluation was one segment of tls stylet.The sample was received with a catheter guillotine.Blood residue was evident throughout the stylet section, which terminated just proximal of the polyimide region.The proximal end of the stylet was stuck in the cut hole of the guillotine.Microscopic inspection of the proximal end of the stylet revealed a glossy surface consistent with a sharp instrument cut.Corresponding damage was observed in the blade of the guillotine.Multiple kinks were observed along the length of the stylet segment.The stylet tip was received in two segments which shared a complete break between magnets approximately midway along the length of the polyimide tubing.The distal segment included the manufactured tip.Microscopic inspection of the sample revealed polyimide deformation at the multiple kink sites.The tubing exhibited deformation, discoloration, buckling and an elliptical cross-section at the break site.The core wire protruded from the tubing of both segments near the break site.Inspection of the break in the core wire revealed a granular fracture surface.Material necking was observed in the vicinity of the break.The break in the stylet was consistent with damage initiated by kinking the stylet between magnets and subsequently exposing the stylet to tensile (pulling) stress.The abundant kinking and stylet deformation were consistent with attempted stylet advancement against resistance without the support of the catheter and can occur if the stylet is advanced beyond the end of the trimmed catheter prior to device insertion.While conditions related to insertion may have contributed to the observed stylet damage, an internal investigation is ongoing to identify additional potential contributing factors.The product ifu states ¿warning: ensure that the stylet tip does not extend beyond the trimmed end of the catheter.Extension of the stylet beyond the catheter end, combined with kinking and excessive forces, may result in vessel damage, stylet damage, difficult removal, stylet tip separation, potential embolism and risk of patient injury.¿ a lot history review (lhr) of recs1790 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC PROVENA CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: 7954435
• Report Number: 3006260740-2018-02869
• Device Sequence Number: 203747
• Product Code: LJS
• UDI-Device Identifier: 00801741112720
• UDI-Public: (01)00801741112720
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• 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,Followup
• Report Date (Section B): 01/03/2019

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: N/A
• Device Catalogue Number: S1385108D
• Device Lot Number: RECS1790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 11/27/2018; 11/27/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 01/03/2019; 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1