MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM; INTRODUCER, CATHETER

Catalog Number 0668945

Device Problems Device Operates Differently Than Expected (2913); Scratched Material (3020)

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

Event Date 06/07/2018

Event Type  malfunction  

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebw0774 showed six other similar product complaints from this lot number.

Event Description

It was reported that there were visible "rough edges" at the end of three guidewires upon their removal from their package.It was stated that each one failed to pass through the needle when attempting insertion.All three devices were unusable, there was no patient involvement.This file addresses the first of the three devices.

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 complaint of damaged guidewires was confirmed, but the exact cause was not determined.A 0.018¿ x 35cm guidewires and a microintroducer was returned for investigation.The guidewire was received in the hoop.The blue tip straightener was not attached to the hoop.The guidewire was extending 9.2cm from the distal end of the hoop.A bend was observed 1.7cm from the distal (exposed) tip of that guidewire.Two less prominent bends were observed 4cm and 8cm from the distal tip.No residue was observed on the microintroducer.A microscopic examination revealed that the weld tip and coil wire was intact at the distal end of the guidewire.Dislocation in the coil wire was observed at the proximal weld tip of the guidewire.The grind pattern on the coil wire was misaligned, which indicates that the dislocation occurred after the guidewire was manufactured.The outside diameter of the guidewire was within specification.This type of damage can occur if the coil wire is twisted near the weld tip; however it is unknown where or how the damage occurred.A lot history review (lhr) of rebw0774 showed six other similar product complaints from this lot number.

Event Description

It was reported that there were visible "rough edges" at the end of three guidewires upon their removal from their package.It was stated that each one failed to pass through the needle when attempting insertion.All three devices were unusable, there was no patient involvement.This file addresses the first of the three devices.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM
• Type of Device: INTRODUCER, CATHETER
• 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7652374
• MDR Text Key: 112996132
• Report Number: 3006260740-2018-01572
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741074530
• UDI-Public: (01)00801741074530
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0668945
• Device Lot Number: REBW0774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Event Location: Hospital
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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