MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 6F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(135CM); 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 redp1968 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the triple lumen stainless steel wire seems to be splitting at the tip.No other information was provided.
Event or Problem Description
It was reported that the triple lumen stainless steel wire seems to be splitting at the tip.No other information was provided.
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, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken guidewire is confirmed and was determined to be use related.One 0.018 in.X 135 cm stainless steel guidewire with a gold tungsten tip in a plastic hoop was returned for evaluation.An initial visual observation showed the coiled wire of the guidewire was unraveled, bent, kinked, and curved.The core wire was observed to be broken and protruding from the coiled wire.A microscopic observation revealed use residue on the returned sample.The break site of the core wire was observed to be curved and slightly tapered, and the fracture surfaces were observed to be mostly flat and granular in texture.The fracture features observed on the returned sample are indicative of failure caused by excessive tensile (pulling) force.This was most-likely caused by withdrawal of the guidewire against resistance which can be caused or complicated by the angle and/or speed of withdrawal, failure to properly hydrate the guidewire prior to use, or damage to the guidewire prior to or during insertion, manipulation, or withdrawal of the guidewire.A lot history review (lhr) of redp1968 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SOLO CATHETER 6F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(135CM)
• 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: 10100729
• Report Number: 3006260740-2020-01874
• Device Sequence Number: 2625304
• Product Code: LJS
• UDI-Device Identifier: 00801741028465
• UDI-Public: (01)00801741028465
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

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 Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 3396135
• Device Lot Number: REDP1968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 05/30/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1