MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redx2449 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redx2449) have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported that at the facility while inspecting the guidewire, the tip broke off easily.The device was not used on a patient.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the stylet could be easily broken was inconclusive due to the state of the sample.The complainant had indicated that the device associated with this complaint was used as part of ¿testing¿ performed at the facility.The damage observed on the returned device was consistent with intentional kinking and pulling on the stylet tip and no formal testing could be performed due to the damaged state of the sample.The product returned for evaluation was an opened kit for a 5fr t/l powerpicc solo catheter.No blood residue, or other evidence of patient use, was seen on any kit component.The stylet within the kit was confirmed to contain a complete break within the magnet tip.The stylet also contained bends and curves throughout the distal region.The polyimide tubing was inspected for evidence of damage, defect, or deformity, which may have existed prior to the facility ¿testing¿ the device and none was found.The stylet wall thickness could not be measured due to the extensive damage found within the magnetic tip.The underlying shrink tubing contained one break, underneath the polyimide layer, which was consistent with tensile/pulling damage.Separation of magnets was seen in a total of six regions with deformation of the shrink tubing within the separation void.Material necking of the polyimide also existed in the same region and both of these observations were consistent with tensile/pulling damage.Tubing wall thickness appeared relatively uniform, but a measurement was not possible due to the damage seen within the region.Evaluation of the stylet wire, wire mandrel, and mandrel sleeve was unremarkable.It could not be determined from the returned device if the stylet was more susceptible to tip breakage as no evidence was observed to support that and the intentionally damaged state of the device prohibited further testing.A lot history review (lhr) of redx2449 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redx2449) have been reported from the same facility in canada.
Event or Problem Description
It was reported that at the facility while inspecting the guidewire, the tip broke off easily.The device was not used on a patient.

• Brand Name: POWERPICC SOLO2 HF CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET 5F
• 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: 9770154
• Report Number: 3006260740-2020-00683
• Device Sequence Number: 14077429
• Product Code: LJS
• UDI-Device Identifier: 00801741035913
• UDI-Public: (01)00801741035913
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 04/09/2020

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: 9395118Q
• Device Lot Number: REDX2449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1