MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 3.5F MICROEZ UNIVERSAL PTFE MICROINTRODUCER SAFETY KIT; INTRODUCER, CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 reby1353 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guidewire was tied in a knot at the tip.Further information has been requested.
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 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 knotted guidewire is confirmed and appears to be related to the use of the device.One guidewire was returned in opened packaging for a 3.5fr microez microintroducer kit.The guidewire was observed to be bent with a knot at the distal end.The length of the guidewire was measured to be 34.8 mm.Use residue was observed on the sample.Microscopic observation of the distal end of the guidewire revealed the guidewire to be intact with the weld tip.The outer diatmeter of the guidewire was measured and found to be within specification.The description of the reported event indicates that multiple attempts at advancement and retraction against resistance were made.Repeated advancement and retraction against resistance and along with the patient¿s anatomy may have contributed to the guidewire becoming knotted; therefore, the complaint is confirmed to be related to the use of the device.The ifu cautions, "be careful when introducing guidewires, since mechanical damage can be inflicted upon the guidewire during insertion or removal of the wire, resulting in possible fracture of the guidewire." a lot history review (lhr) of reby1353 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guidewire was tied in a knot at the tip.Further information has been requested.

• Brand Name: 3.5F MICROEZ UNIVERSAL PTFE MICROINTRODUCER SAFETY KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8142035
• Report Number: 3006260740-2018-03496
• Device Sequence Number: 16196901
• Product Code: DYB
• UDI-Device Identifier: 00801741038365
• UDI-Public: (01)00801741038365
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K915167
• 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): 01/17/2019

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: 0678935
• Device Lot Number: REBY1353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1