MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 NICORE NITINOL GUIDEWIRE

Catalog Number 150NFS35

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.

Event Description

It was reported that the guidewire broke while it was advanced inside the patient's body and the broken guidewire was replaced with a new guidewire.After the break, it was clamped out with forceps, and there was no adverse reaction for the time being.Per follow up information received via ibc on 17nov2023, stated that the broken guidewire has been sent to the patient for removal, and it has been clamped out little by little with a clip.

Event Description

It was reported that the guidewire broke while it was advanced inside the patient's body and the broken guidewire was replaced with a new guidewire.After the break, it was clamped out with forceps, and there was no adverse reaction for the time being.Per follow up information received via ibc on 17nov2023, stated that the broken guidewire has been sent to the patient for removal, and it has been clamped out little by little with a clip.

Manufacturer Narrative

The reported event event is confirmed cause unknown.Visual evaluation noted received 1 photo sample.Photo sample shows guidewire enclosed within packaging with a red circle indicating flaking present within guidewire.Therefore, product does not meet specifications.Although an exact root cause could not be determined a potential root cause could be inadequate material selection.Dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: ¿guidewires are used to provide access and facilitate passage of endourological instrumentation during urological procedures.Hydrophilic guidewires are offered in many different configurations that include: sizes (lengths and diameters), tip designs, and stiffness.The bard® nicore¿ wire has a nitinol core and a hydrophilic coating.The bard® hydro-glide¿ stainless steel guidewires are available with a hydrophilic coating.Indications: bard® guidewires are indicated to provide transurethral and/or percutaneous access into the bladder, ureter or renal pelvis.Contraindications: there are no known contraindications warning: inspect all guidewires for damage prior to use.Bending or kinking during or prior to placement could damage the guidewire.Do not attempt to use the guidewire if it has been damaged.Use of a damaged wire may result in damage to the urinary tract.Do not reshape the guidewire by any means.Attempting to reshape the guidewire may cause damage resulting in release of fragments into the urinary tract.Failure to exercise proper caution may result in damage to the urinary tract.Do not manipulate or remove the guidewire through a metal cannula or needle.This may result in destruction/separation of the outer jacket of the wire requiring retrieval.Use extreme caution when using a laser, making sure to avoid contact with the wire.Direct contact could result in damage / breakage to the wire.Attention should be paid to guidewire movement in the urinary tract.Before a guidewire is moved or torqued, tip movement should be examined under direct vision or fluoroscopy.Do not advance or withdraw a guidewire when resistance is encountered as perforation could occur.Sufficient guidewire length must remain exposed to maintain a firm grip on guidewire at all times.Failure to comply with the warnings could result in damage to the guidewire to include, but not limited to: wire breakage, abrasion of the coating, release of guidewire fragments into the urinary system, all of which might require intervention.This is a single use device.Do not resterilize any portion of this device.Reuse and/ or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Precautions: should be used only by physicians thoroughly trained in endourological guidewire techniques.Do not use dry gauze to manipulate the guidewire as this can damage the surface coating and make the wire tacky.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Potential complications: complications that may result from the use of a guidewire in a urological procedure incude, but are not limited to: ¿ perforation, ¿ acute or delayed bleeding, ¿ tissue trauma, ¿ edema.Direction for use: the physician should select the proper size and length of the guidewire for the procedure being performed.1.The guidewire is packaged in a protective coil.Hydrophilic coated guidewires require activation of their coating.Prior to removing the guidewire from the protective coil, inject sterile saline through the port to activate the lubricious coating.Remove the guidewire from the protective coil and carefully inspect the guidewire for separation, bends, kinks or a damaged tip.2.Introduce the guidewire, flexible end first, into the working channel of the endoscopes or percutaneously into the urinary tract.3.Advance the guidewire slowly into the desired position.Continuously confirm guidewire position either visually or under fluoroscopy.4.Carefully withdraw the guidewire taking care not to kink.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable local, state and federal laws and regulations.¿ h11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: NICORE NITINOL GUIDEWIRE
• Type of Device: NITINOL GUIDEWIRE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18236621
• MDR Text Key: 329356251
• Report Number: 1018233-2023-08638
• Device Sequence Number: 1
• Product Code: EZB
• UDI-Device Identifier: 00801741051487
• UDI-Public: (01)00801741051487
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150NFS35
• Device Lot Number: NGGU2809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• 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): Other