MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refw0268 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "easy placement, centered, advanced wire completely forward it felt odd, tried pulling back the purple button and it was stuck, tried advancing green wings and that felt odd.So aborted.When pulling out the device the cannula easily came out of the patient but the wire remained in the tissue.Noticed unraveling of the wire.Carefully removed entire wire from within patients arm.Wire tip looked to be intact.".

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed.One 18g powerglide pro catheter and deployment system were returned for investigation.The deployment system was received with the safety mechanism deployed over the needle tip.A break in the core wire was observed, which allowed the coil wire to stretch over the core wire.A microscopic examination revealed that no portion of the guidewire was missing.The break in the core wire coincided with the sharp edge of the needle bevel.A pattern of impressions and scratches that appeared to be consistent with the pattern of the guidewire coils was observed along the inner edge of the needle bevel.A 2mm slit was observed in the catheter.It was reported that something felt odd during the insertion procedure.The catheter and guidewire may have been forced against the sharp edge of the needle bevel.The instructions for use (ifu) warn, ¿once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿.

Event Description

It was reported "easy placement, centered, advanced wire completely forward it felt odd, tried pulling back the purple button and it was stuck, tried advancing green wings and that felt odd.So aborted.When pulling out the device the cannula easily came out of the patient but the wire remained in the tissue.Noticed unraveling of the wire.Carefully removed entire wire from within patients arm.Wire tip looked to be intact.".

• Brand Name: FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13005310
• MDR Text Key: 282265783
• Report Number: 3006260740-2021-05291
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140563
• UDI-Public: (01)00801741140563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F118108PT
• Device Lot Number: REFW0268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 02/24/2022
• Supplement Dates FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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