MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE HYDROPHILIC GUIDEWIRE; UROLOGICAL CATHETER AND ACCESSORIES

Model Number M006630222B1

Device Problem Material Integrity Problem (2978)

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

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not received for evaluation at the time of this report; therefore no physical analysis of the device can be performed.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The supplied images appear to present an undetermined length of the polymer jacket detached from the distal tip, exposing the underlying metallic core wire.During manufacturing the production operators are instructed to 100% visually and tactilely inspect for any obvious defect, which includes a tactile examination of the entire length of each wire.In addition, during packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As indicated in the directions for use (dfu) precautions, "the surface of the zipwire hydrophilic guidewire is not lubricious unless it is wet.Before taking it out of its holder and inserting it through a catheter, fill the holder and the catheter with sterile physiological saline solution." as noted in the dfu operational instructions, "to activate hydrophilic coating: before removing the zipwire hydrophilic guidewire from the protective hoop (by its distal end), inject physiological saline solution into the hub end of the holder in order to completely wet the surface of the wire." at this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided and the supplied imagery it appeared that handling factors contributed to the event as reported.If there is any further relevant information received, a follow up medwatch report will be submitted.

Event Description

It was reported that on (b)(6) 2021, the patient was admitted to hospital due to ureteral calculus.At 9pm, dj catheter placement was needed under guidance of a hydrophilic guidewire.The physician unpacked the guidewire and found one end of the hydrophilic guidewire had no hydrophilic layer, and the inner metal layer of the guidewire was exposed.The physician stopped using the guidewire.The procedure was completed with another guidewire and the physician reported the issue to hospital.

Manufacturer Narrative

Device evaluation: as received, the specimen consists of one each hydro gw stf std s 150-035; returned coiled, loose, accompanied by the labelled portion of the packaging pouch and double-bagged within "zip-lock" style poly biohazard pouches.The dispenser assembly was not returned with the specimen device.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.During manufacturing the production operators are instructed to 100% visually and tactilely inspect for any obvious defect, which includes a tactile examination of the entire length of each wire.In addition, during packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The specimen presents a ductile, tensile overload fracture of the polymer jacket resulting in the removal of an undetermined length of the polymer jacket, exposing the distal 0.45cm of the metallic core wire and a large radius bend over the distal 5.50cm, consistent with tensile loading.Our investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.The dispenser assembly was not returned with the specimen device; preventing verification that the system was properly prepared for use.As indicated in the directions for use (dfu) precautions, "the surface of the zipwire hydrophilic guidewire is not lubricious unless it is wet.Before taking it out of its holder and inserting it through a catheter, fill the holder and the catheter with sterile physiological saline solution." as noted in the dfu operational instructions, "to activate hydrophilic coating: before removing the zipwire hydrophilic guidewire from the protective hoop (by its distal end), inject physiological saline solution into the hub end of the holder in order to completely wet the surface of the wire." at this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, it appears that handling and/or procedural factors have contributed to the event as reported.If there is any further relevant information provided, a follow up medwatch report will be submitted.

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Type of Device: UROLOGICAL CATHETER AND ACCESSORIES
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 11716382
• MDR Text Key: 249134291
• Report Number: 2126666-2021-00013
• Device Sequence Number: 1
• Product Code: EYA
• UDI-Device Identifier: 08714729755326
• UDI-Public: 08714729755326
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: M006630222B1
• Device Catalogue Number: 630-222B
• Device Lot Number: 5754181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR