MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INC. RADSTIC RADIOLOGY MICROINTRODUCER KIT PTFE

Catalog Number 0669050

Device Problem Knotted (1340)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Facility reported to sales representative that they had a reported issue with the radstic microintroducer kits.The second kit was said to have had the wire allegedly knot at the end and reportedly got stuck in the pt.The pt reportedly had to be cut in order to get the guidewire out.

Manufacturer Narrative

The info provided by bard represents all of the known info at this time.Despite good faith efforts to obtain additional info, the complainant/ reporter was unable or unwilling to provide any further pt, product, or procedural details to bard.A lot history review (lhr) of rezc2122 showed no other similar product complaint(s) from these lot numbers.The mfr has received the sample and will be evaluated.Results are expected soon.

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 complaint of a kinked or knotted guidewire is confirmed, cause unknown.The product implicated is a ptfe 5 fr x 10cm radstic micro introducer kit.The complainant ((b)(6) medical center) has provided manufacturer with two photos of the alleged complaint sample.The loose nature of the wire implies turbulence within the central venous system may have initiated the guidewire looping over itself, forming a loose knot.The loose knot probably impeded the guidewire from being removed and the outer coils proximal to the knot became elongated and stretched.At this time the mechanism of damage to the catheter is undetermined.It should be noted that if the sample is made available to manufacturer this file will be re-opened and the complaint sample will be re-evaluated at that time.

• Brand Name: RADSTIC RADIOLOGY MICROINTRODUCER KIT PTFE
• Manufacturer (Section D): BARD ACCESS SYSTEMS INC.; salt lake city UT
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. ; blvd. montebello #1 ; parque industrial colonial ; reynosa, tamaulipas ; MX
• Manufacturer Contact: christy chandonia ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225631
• MDR Report Key: 4955789
• MDR Text Key: 6191090
• Report Number: 3006260740-2015-00347
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2015

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: 0669050
• Device Lot Number: REZC2122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/17/2015
• Initial Date FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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