MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4.5 FR. RADSTIC MICRO INTRODUCER KIT WITH PTFE; CATHETER INTRODUCER

Catalog Number	0669045
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2017
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 reat0796 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that the wire sheared off while inserting the device.A new kit was opened to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
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 reported incident of a damaged guidewire was confirmed, and the cause appeared to be use related.One 0.018¿ x 70cm stainless steel guidewire was returned for investigation.The proximal end of the guidewire was received in its hoop.The tip straightener was removed from the hoop and was not returned for investigation.The core wire extended 5.3cm from the proximal attachment point of the coil wire.The coil wire was stretched and unraveled over the fractured end of the core wire.The distal 3cm of the coil wire was tightly coiled.The core wire broke 2.8cm from the distal weld tip.The weld tip was intact.The fractured ends of the core wire were granular, which is indicative of a tensile break.Biological residue was observed on the external surface of the coil wire at the proximal end of the 3cm segment of tightly coiled wire, which is consistent with damage that is associated with retraction of the guidewire through the needle.When biological residue becomes lodged between the guidewire and needle as the guidewire is retracted, the wire can break.The tightly coiled wire indicates that the distal section of coil wire was constrained while the proximal section of coil wire was stretched and elongated over the broken core wire.Due to the evidence of use, the damage was determined to be use related.A lot history review (lhr) of reat0796 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that the wire sheared off while inserting the device.A new kit was opened to complete the procedure.No patient injury reported.

• Brand Name: 4.5 FR. RADSTIC MICRO INTRODUCER KIT WITH PTFE
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7070624
• Report Number: 3006260740-2017-02155
• Device Sequence Number: 16433378
• Product Code: DYB
• UDI-Device Identifier: 00801741074578
• UDI-Public: (01)00801741074578
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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 Catalogue Number: 0669045
• Device Lot Number: REAT0796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1