MAUDE Adverse Event Report: HANGZHOU BEVER MEDICAL DEVICES CO., LTD. SOLO HYBRID WIRE 38 FLEX STRT; GUIDEWIRE

Catalog Number HW38FS

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/25/2023

Event Type  Injury  

Event Description

It was reported that the solo flex hybrid guidewire was used for the patient.It was advanced alongside a preexisting stent at the right ureteric orifice up to the right renal pelvis under fluoroscopic guidance.Two days after post operation the patient reported during urination a black flexible tube was passed.At a post operation office visit when shown a solo flex guidewire tip believed that was what was passed during urination.

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.H3 other text : the device was not returned.

Event Description

It was reported that the solo flex hybrid guidewire was used for the patient.It was advanced alongside a preexisting stent at the right ureteric orifice up to the right renal pelvis under fluoroscopic guidance.Two days after post operation the patient reported during urination a black flexible tube was passed.At a post operation office visit when shown a solo flex guidewire tip believed that was what was passed during urination.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be user does not utilize recommended technique per ifu.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "warnings: a thorough understanding of the technical principles, clinical applications, and risks associated with the use of guidewires is necessary before using this product.This device is restricted to use by or under the supervision of physicians trained in urologic endoscopic procedures.Care should be exercised to prevent perforation or trauma of the linings and associated tissue, channels or ducts.¿ failure to abide by the following warnings might result in damage to the channel or duct, abrasion of the hydrophilic coating, release of plastic fragments from the guidewire, damage to or breakage/separation of the guidewire, that may necessitate intervention.¿ manipulate the guidewire slowly and carefully in the urinary system while confirming the behavior and location of the wire¿s tip under fluoroscopy.Excessive manipulation of the guidewire without fluoroscopic confirmation may result in perforation or trauma of the linings or associated tissues, channels or ducts.If any resistance is felt or if the tip¿s behavior and/or location seems improper, stop manipulating the guidewire and/or the catheter and determine the cause by fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the guidewire¿s tip, damage to the catheter, or damage to the urinary system.If necessary, remove the guidewire and ancillary device or scope as a complete unit to avoid complications.Recommended technique: remove the guidewire from the protective hoop.Save the hoop to store the guidewire if it will be used again during the same procedure on the same patient.Before using, inspect the guidewire for the following: roughness or abrasion at the tip.Kinking along the length of the guidewire.The guidewire may be introduced into the patient in any of the following manners: place the guidewire via a scope into the ureter first, to gain initial access before placing a catheter over the guidewire.Note: the bard® solo¿ hydro hybrid guidewire is hydrophilic on the shaft and should be re-hydrated prior to placing a catheter.If the wire dries out it may be difficult to advance instruments over the wire.Preload a catheter over the guidewire and place as a complete unit into the ureter.Back-load the guidewire through a replaced catheter.Note: keep at least 5cm (1.96") of the wire extended out of the proximal end of the scope or catheter during introduction at all times.Carefully and slowly withdraw the guidewire from the patient to avoid any kinking." 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 device was not returned.

• Brand Name: SOLO HYBRID WIRE 38 FLEX STRT
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): HANGZHOU BEVER MEDICAL DEVICES CO., LTD.; no. 8-1, longquan road; cangqian town, yuhang district; hangzhou, zhejiang 31112 1; CH 311121
• MDR Report Key: 17730164
• MDR Text Key: 323195981
• Report Number: 1018233-2023-06725
• Device Sequence Number: 1
• Product Code: EZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2023,10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HW38FS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/21/2023
• Event Location: Other
• Date Report to Manufacturer: 09/01/2023
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 118 KG