MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5F MICROEZ MICROINTRODUCER SAFETY KIT; CATHETER INTRODUCER

Catalog Number	0688950
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/10/2015
Type of Reportable Event	Serious Injury
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that in preparation for picc insertion, the provider accessed the patient's right basilica vein.A microez introducer guide wire (35cm) was threaded with resistance.The introducer was threaded over wire.When provider was trying to reverse the wire they were unable to do so.An x-ray was done and the alleged knot in the guide wire was noted.An incision was made to remove it and the patient required sutures to close the wound.
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, trend 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 knot in the guidewire was confirmed, but the exact cause of the complaint is unknown.The guidewire was received with a slipknot tied 32.5cm from the proximal end of the guidewire.A microscopic examination of the guidewire revealed dislocations in adjoining coils of the coil wire at the knot.A tactual investigation revealed that the coil wire was intact over the core wire.It was reported that the guidewire was advanced in the right basilica vein with resistance during use.It is possible that the wire inadvertently folded over itself and was twisted into a knot within the vein.No manufacturing related defects were noted on the complaint sample.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.

• Brand Name: 5F MICROEZ MICROINTRODUCER SAFETY KIT
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5398685
• Report Number: 3006260740-2016-00009
• Device Sequence Number: 453390
• Product Code: DYB
• UDI-Device Identifier: 00801741038426
• UDI-Public: (01)00801741038426
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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
• Type of Report: Followup
• Report Date (Section B): 01/04/2016

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0688950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2016
• Supplement Report FDA Received Date: 04/28/2016
• 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