MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (70 CM NITINOL GUI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reeq1397 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that part of the wire from one of the bard picc kits broke off during a picc procedure.The wire was retrieved additional information received 9/16/2020: it was reported the patient experienced temporary harm as an additional procedure was required for the foreign body retrieval.
Event or Problem Description
It was reported that part of the wire from one of the bard picc kits broke off during a picc procedure.The wire was retrieved additional information received 9/16/2020: it was reported the patient experienced temporary harm as an additional procedure was required for the foreign body retrieval.
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 review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken guidewire is confirmed.One 0.018 in.Guidewire segment was returned for evaluation.An initial visual observation showed use residue on the returned sample.The guidewire segment was found to be knotted toward its distal tip.The guidewire segment was measured to be approximately 4 cm long.A microscopic observation revealed the break site of the coiled wire was angled but mostly flat and smooth.The guidewire was found to be looped around itself multiple times at the location of the knot, and biological residue was observed around and within this knot.The coiled wire was observed to begin to unravel at the proximal end of the knot suggesting tensile (pulling) force was applied to the guidewire after the knot was formed, which ultimately caused the guidewire to fracture.The knot near the distal end of the returned guidewire segment was most-likely caused by repeated advancement and retraction of the guidewire against resistance.The product ifu states: ¿do not use excessive force when introducing guidewire or microintroducer as this can lead to vessel perforation and bleeding.¿.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (70 CM NITINOL GUI
• 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: 10620534
• Report Number: 3006260740-2020-03430
• Device Sequence Number: 3232566
• Product Code: LJS
• UDI-Device Identifier: 00801741028144
• UDI-Public: (01)00801741028144
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 3295355
• Device Lot Number: REEQ1397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Weight: 109