MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 NITINOL CORE GUIDEWIRE, .035", 3 CM, STRAIGHT, STIFF, 150 CM LENGTH

Catalog Number 150NSS35

Device Problems Product Quality Problem (1506); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that while performing the urethral calculus surgery and getting ready to place the guide wire, no hydrophilic coating was found on the tip when the package was opened.

Manufacturer Narrative

The reported event was confirmed, as cause unknown.Evaluation report of the returned sample, submitted by memry corporation, stated that 0.250" of the nitinol guide wire was exposed at the distal end.The jacketing appeared to have been stripped from the wire.The report also stated that a review of inspection records showed no issues.There were no previous non-conformances or scraps with this issue.A potential root cause could be a cutting error during memry¿s operations.The condition was obviously missed during the visual inspection of the parts as there is no record of it during inspection; the final inspection is based on a sampling plan and due to the size of the lots involved, could easily have been missed as this does appear to be a one-time occurrence.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿description: guidewires are used to provide access and facilitate passage of endourological instrumentation during urological procedures.They are offered in many different configurations that include: sizes (lengths and diameters), tip designs, coatings (hydrophilic and ptfe) 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.The bard® stainless steel guidewires are available with and without ptfe and are available in fixed and movable core.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.".

Event Description

It was reported that while performing the urethral calculus surgery and getting ready to place the guide wire, no hydrophilic coating was found on the tip when the package was opened.

• Brand Name: NITINOL CORE GUIDEWIRE, .035", 3 CM, STRAIGHT, STIFF, 150 CM LENGTH
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8944370
• MDR Text Key: 188892025
• Report Number: 1018233-2019-05193
• Device Sequence Number: 1
• Product Code: EZB
• UDI-Device Identifier: 00801741051524
• UDI-Public: (01)00801741051524
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Catalogue Number: 150NSS35
• Device Lot Number: NGCY2228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 65