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

Model Number M006630222B1

Device Problems Device Damaged by Another Device (2915); Insufficient Information (3190)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

Although there is no mention of the zipwire device included in the incident description, the lot number and device description reference's a zipwire hydrophilic non-vascular guidewire.This report is being filed based on the pre-disposition to report rather than not report.Requests for further clarification have been submitted to the distributor and at the time of this response it is unknown what involvement the zipwire hydrophilic non-vascular guidewire had in this case.At the time of this report, no product has been returned for evaluation.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 noted in the device instructions for use (dfu) warnings, "do not manipulate, advance and/or withdraw the zipwire hydrophilic guidewire through a metal cannula or needle.Manipulation, advancement, and/or withdrawal through a metal device may result in destruction and/or separation of the outer polymer jacket requiring retrieval.If a needle is used for initial placement, a plastic entry needle is recommended when using the zipwire hydrophilic guidewire.Extreme caution should be observed when used with a one-wall puncture needle." the dfu precautions also indicate, "the zipwire hydrophilic guidewire should be advanced through the scope using short, deliberate 2-3cm movements to prevent inadvertent damage to the device or patient." at this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, clinical and/or procedural factors appear to have impacted on the event as reported.The patient information is unknown.If there is any further relevant information provided, a follow up medwatch report will be submitted.

Event Description

Event description: it was reported that: left percutaneous nephrostomy: ultrasound identification of the left kidney which was dilated.Puncture of the lower caliceal group with clear urine output under pressure.Injection of contrast medium to visualize the pyelocaliceal cavities.Placement of a metal guidewire in the pyelocaliceal cavities without difficulty.Expansion of the functional path and placement of a nephrostomy probe ch 12 in the arch located in the left pelvis.The probe was fixed with 2 zero resorbable thread.Right nephrostomy: puncture of the lower right caliceal group under ultrasound.Ejection of contrast medium which found a kidney that was abnormally rotated.They tried to place a metal guidewire in the pelvic cavities but it remained stuck at the level of the lower caliceal group.A terumo guide was placed at the level of the lower caliceal group.The terumo guide passed easily through the pelvis.However, it was not possible to withdraw the terumo because it was stuck.A moderate traction caused a stripping of the terumo distal sheath which unfortunately remained in the pyelocaliceal cavities.We had to repair with another needle in the lower caliceal group in order to remove the needle and the stuck terumo.Renewed opacification of the cavities followed by placement of the nephrostomy at the level of the right pelvis.We ensured its correct position by injecting contrast product.The probe is attached to the skin by the 2 zero resorbable thread.Placement of skin drainage bag.In total we are reporting a materiovigilance problem due to a ureteral guide which has lost its sheath in the right pyelocalyceal cavities.Actions taken in the healthcare establishment: removal of the manufacturer's guidewires of the same lot number.

Manufacturer Narrative

Note: this report is being submitted due to the additional information received, which has been added in section b5.In addition section h6 has been update to reflect the additional information.At the time of this report, no product has been returned for evaluation.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 noted in the device instructions for use (dfu) warnings, "do not manipulate, advance and/or withdraw the zipwire hydrophilic guidewire through a metal cannula or needle.Manipulation, advancement, and/or withdrawal through a metal device may result in destruction and/or separation of the outer polymer jacket requiring retrieval.If a needle is used for initial placement, a plastic entry needle is recommended when using the zipwire hydrophilic guidewire.Extreme caution should be observed when used with a one-wall puncture needle." the dfu precautions also indicate, "the zipwire hydrophilic guidewire should be advanced through the scope using short, deliberate 2-3cm movements to prevent inadvertent damage to the device or patient." at this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, clinical and/or procedural factors appear to have impacted on the event as reported.The patient information is unknown.If there is any further relevant information provided, a follow up medwatch report will be submitted.

Event Description

Additional information was received from the distributor on (b)(6) 2020 reporting that the mentioned product is indeed a zipwire even though they mention a terumo guide.It was also reported that part of the distal cover of the wire stayed in the kidney.On (b)(6)\ 2020, it was reported that there was no date provided from the hospital regarding an additional procedure.

• 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: 10553319
• MDR Text Key: 207525839
• Report Number: 2126666-2020-00066
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention