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

Catalog Number 0668945

Device Problems Kinked (1339); Sticking (1597)

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

Event Date 10/04/2017

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 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 guidewire getting stuck on the introducer sheath is confirmed, but the cause is unknown.The sample returned consisted of one damaged 4.5 fr introducer sheath and a damaged guidewire.Visual observation found that the 4.5 fr introducer sheath was bent at the distal end and the distal orifice was deformed.The sheath was not split at all.The shaft was wrinkled along the inside of the bend and the orifice was approximately teardrop-shaped, with the narrow end pointing in the bend direction.This damage is consistent with the wire and the introducer sheath being pushed against each other.One end of the guidewire was bent and kinked, with some coils out of alignment.The wire was not broken.The guidewire outer diameter was measured and not found to be out of specification.The condition of the sample does not allow the determination of a definite root cause; if the guidewire damage seen now had even partly occurred prior to insertion into the dilator, such kinking might have caught on the sheath tip, as observed.However, all observed damage might also have occurred due to rough handling during use.It should be noted, however, that the ifu states to remove the dilator and guidewire together after the introducer has been advanced.The following statements from the ifu may be useful: ¿¿ simultaneously advance the sheath and dilator with rotational motion to help prevent sheath damage.¿ be careful when introducing guidewires, since mechanical damage can be inflicted upon the guidewire during insertion or removal of the wire, resulting in possible fracture of the guidewire.¿ ¿4.Gently withdraw and remove the introducer needle or catheter, while holding the guidewire in position.Caution: if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.5.Advance the small sheath and dilator together as a unit over the guidewire, using a slight rotational motion.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.Verify institutional guidelines concerning the use of a scalpel prior to making incision.6.Withdraw the dilator and guidewire, leaving the small sheath in place.¿ a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reportedly not smooth during catheter insertion with the guidewire and it got stuck in the end.No reported patient injury.On (b)(6) 2018, the returned guidewire is kinked.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7293253
• MDR Text Key: 101065492
• Report Number: 3006260740-2018-00277
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741074530
• UDI-Public: (01)00801741074530
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0668945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/02/2018
• 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