MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number CK000587A

Device Problems Folded (2630); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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 guidewire is confirmed but the cause is unknown.Three photo samples of guidewire within a dual lumen powerpicc solo was returned for evaluation.The guidewire was shown to be bent over itself within the catheter in the second photo.The third photo showed the guidewire extended from the distal end of the catheter revealing a kink.Based on the description of the reported event and photo samples provided, possible contributing factors include advancement of guidewire against resistance.As the guidewire was observed to be bent over itself within the catheter and was kinked, the complaint is confirmed.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that a dl power picc solo line placement was attempted an the guidewire was folded over back up into the catheter and torn between the two lumens.Another device was used to complete the procedure.No patient injury was reported.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7384008
• MDR Text Key: 104077738
• Report Number: 3006260740-2018-00566
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741135033
• UDI-Public: (01)00801741135033
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CK000587A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1