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

Catalog Number 0688950

Device Problem Knotted (1340)

Patient Problem No Code Available (3191)

Event Date 10/10/2015

Event Type  Injury  

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 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.

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
• Type of Device: CATHETER INTRODUCER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 5398685
• MDR Text Key: 37103825
• Report Number: 3006260740-2016-00009
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741038426
• UDI-Public: (01)00801741038426
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 0688950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention