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

Model Number M006630222B1

Device Problem Device Handling Problem (3265)

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

Event Date 09/29/2021

Event Type  malfunction  

Event Description

Event description: it was reported that during preparation, it was found the inner core was exposed, it could not be used.The device is expected to be returned before nov.9th.There were no patient complications reported.Is clinical? no.What was the patient condition following procedure? stable.Where did the problem occur? inside the patient.Was the problem associated with labeled used? yes.Action taken by the physician to try to resolve the event: none.Patient outcome from the event: none.Event resolved? yes.Additional information received on november 1, 2021: the complaint narrative states the issue was found during preparation; however, the narrative also indicates that the wire was inside the patient.Please provide clarification.Was it the first time the device was used? if not, how many times had it been? yes.Was there visible damage to the device and/or its packaging prior to use? yes.If damage was noted, where on the wire was the damage? only knew it was on the wire.Was the specimen properly prepared for use? no.Was the dispenser assembly injected with enough physiological saline to completely wet the specimen wire before removing it from the dispenser assembly? no.How was the procedure(s) completed? (i.E.Was the same device exchanged for another of the same, different device, etc.)? completed with another of same device listing and model of other devices used during the procedure? only knew the device is for broken stone by holmium laser was there an issue with lubricity of the device? no.Did the physician encounter any resistance while advancing the zipwire to its intended location? no, it has never been inside the patient.Was the zipwire advanced through a metal cannula or needle? no.Did any part of the guidewire detach inside the patient? no.Is there an image available? no.

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.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." the complaint is non-verifiable as the product was not returned for evaluation.Follow-up communication indicated that the end user did not hydrate the wire in the dispenser assembly as described in the dfu.At this time, it appears that handling during preparation impacted on the event as reported.If any further information is received, a follow up medwatch report will be submitted.

Manufacturer Narrative

Device evaluation: as received, the specimen consisted of one-1 each hydro gw stf std s 150-035; returned reloaded into a partial dispenser and double-bagged within "zip-lock" style poly pouches.The specimen presented an overall length of 148.35cm due to mechanical shear/cut of the distal end of the core wire and a finished diameter of.03350" to.02785".The specimen presented a polymer jacket separation at the distal tip presenting indications of ductile, tensile overload exposing approximately 0.15cm of the metallic core wire.The distal end of the exposed metallic core wire presented indications of mechanical shear/cut.The specimen also presented a large radius bend over the distal 7.80cm, consistent with tensile loading.Except where noted, the specimen device appeared visually and dimensionally correct.As noted in the additional information received 1 november 2021, the specimen was not prepared for use in accordance with the device instructions for use.The damage observations noted above are representative of the effects of attempting to remove an un-hydrated wire from a dispenser.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." 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.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.Based on the information provided and the evidence presented, handling during preparation for use contributed to the event as reported.If any further information is received, a follow up medwatch report will be submitted.

Event Description

Event description: it was reported that during preparation, it was found the inner core was exposed, it could not be used.The device is expected to be returned before nov.9th.There were no patient complications reported.Is clinical? no what was the patient condition following procedure? stable where did the problem occur? inside the patient was the problem associated with labeled used? yes action taken by the physician to try to resolve the event: none patient outcome from the event: none event resolved? yes additional information received on november 1, 2021: the complaint narrative states the issue was found during preparation; however, the narrative also indicates that the wire was inside the patient.Please provide clarification.Was it the first time the device was used? if not, how many times had it been? yes.Was there visible damage to the device and/or its packaging prior to use? yes.If damage was noted, where on the wire was the damage? only knew it was on the wire.Was the specimen properly prepared for use? no.Was the dispenser assembly injected with enough physiological saline to completely wet the specimen wire before removing it from the dispenser assembly? no.How was the procedure(s) completed? (i.E.Was the same device exchanged for another of the same, different device, etc.)? completed with another of same device listing and model of other devices used during the procedure? only knew the device is for broken stone by holmium laser was there an issue with lubricity of the device? no.Did the physician encounter any resistance while advancing the zipwire to its intended location? no, it has never been inside the patient.Was the zipwire advanced through a metal cannula or needle? no.Did any part of the guidewire detach inside the patient? no.Is there an image available? no.

• 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
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: victoria foss ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418506
• MDR Report Key: 12788160
• MDR Text Key: 282716979
• Report Number: 2126666-2021-00047
• Device Sequence Number: 1
• Product Code: EYA
• UDI-Device Identifier: 08714729755326
• UDI-Public: 08714729755326
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: M006630222B1
• Device Catalogue Number: 630-222B
• Device Lot Number: 11194296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 70 KG