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

Model Number	CK000411
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 initial complaint appeared to be a non-reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had occurred.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 bent 3cg stylet was confirmed, with an additional complete break within the stylet tip.The cause was determined to be use related.The product returned for evaluation was a 3cg stylet assembly.The stylet contained a complete break within the polyimide magnet tip and the broken segment was measured to be approximately 1.9¿ in length.Microscopic examination of the fracture sites found that the tip near the fracture site of each end was sharply curled and contained kinks at each magnet interface.All magnets were present and accounted for.Further microscopic examination revealed tensile elongation of the polyimide tubing at the break site of the distal fragment.These features were characteristic of both a tensile and kink-related event.It is likely that either the stylet tip had extended beyond the tip of the catheter during stylet withdrawal or the catheter tip was kinked during the stylet withdrawal.Discontinuing stylet withdrawal when resistance is encountered will avoid this type of event.Withdraw both the stylet and catheter together as a unit if resistance is encountered during stylet withdrawal.A lot history review (lhr) of rebv1469 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the wire was bent at the end and needed to be removed from patient.No other information was provided.On 5/2/2018 - returned wire is bent and broken.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET MAXIMAL
• 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: 7541046
• Report Number: 3006260740-2018-01086
• Device Sequence Number: 275502
• Product Code: LJS
• UDI-Device Identifier: 00801741096303
• UDI-Public: (01)00801741096303
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

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: CK000411
• Device Catalogue Number: CK000411
• Device Lot Number: REBV1469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1