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

Catalog Number 0668945

Device Problem Bent (1059)

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

Event Date 12/22/2017

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 initial complaint appeared to be a non-reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had occurred.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 a damaged guidewire is confirmed; however the exact cause is unknown.One stainless steel guidewire and a plastic guidewire hoop were returned for evaluation.An initial visual observation showed the guidewire was bent approximately 2.2 cm proximal to its distal end.The plastic guidewire hoop was observed to be damaged approximately 4.4 cm proximal to the distal end of the hoop and appeared to have been compressed.A microscopic observation revealed kinking at three locations near the bend observed in the guidewire.Plastic deformation was observed on the outside of the plastic guidewire hoop and the outer surface of the hoop was observed to be more lustrous near the location of the deformation.An indentation was observed on the interior wall of the plastic hoop at the location of the damage and ridges that match the pattern of the guidewire coils were observed in this indentation.The guidewire was inserted fully into the plastic hoop and it was observed that the damage on the guidewire was approximately 3.5 cm away from the damage on the hoop.A very slight bent was observed in the guidewire approximately 7 cm proximal to its distal tip, which could have been within the plastic guidewire hoop at the location of the damage on the hoop.The characteristics of the deformation observed on the plastic guidewire hoop as well as the luster observed at the site of the damage suggest the hoop was compressed and also possibly exposed to excessive heat.This damage, as well as the bends and kinks observed in the guidewire, may have occurred during storage, handling, or shipping; however, it is not possible to determine when or where the guidewire and guidewire hoop sustained the observed damage.A lot history review (lhr) of reau1293 showed no other similar product complaint(s) from this lot number.

Event Description

It was that the guidewire was found to be bent during product inspection before catheter placement.A new device was used to complete the procedure.There was no reported patient injury.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5C
• 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7422443
• MDR Text Key: 105306834
• Report Number: 3006260740-2018-00664
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741074530
• UDI-Public: (01)00801741074530
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• 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: REAU1293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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