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

Model Number	M0066802081
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The age of the patient is not noted as the event date was not reported.It was reported that the device will not return; 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 noted in the device instructions for use (dfu) warnings, use extreme caution when using a laser, making sure to avoid contact with the zipwire hydrophilic guidewire.Direct contact may cause damage to the wire and/or sever the wire.Information received 13 june 2022 indicated the bsc representative spoke with a representative at the hospital.He stated he was at the hospital this morning and spoke to a doctor who reported it was a case of the physician lasered off the end of the guidewire by accident.There were no patient injuries.Based on the information provided, it appeared that procedural factors may have impacted on the event as reported.If any further information is received, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: per email, it was reported that: our surgeon was performing a cystoscopy, left ureteroscopy, laser lithotripsy, stent.At end of procedure it was noticed on x-ray images that a foreign body was in the patients kidney.Surgeon stated it was part of the wire that must have broke off.The wire was examined and it appeared to have one end that was not normal appearing.The doctor then had to remove the stent and go back in to retrieve the broken wire.He was able to successfully retrieve the broken piece of wire.The defective zipwire and the piece that had broken off the end was compared to a new zipwire and it was determined by measuring that the lengths were equal.X-ray images were clear and confirmed by the doctor.Additional information received 13 june 2022: the bsc representative spoke with a representative at the hospital.He stated he was at the hospital this morning and spoke to a doctor who reported it was a case of the physician lasered off the end of the guidewire by accident.There were no patient injuries.
Additional Manufacturer Narrative
Correction to section g4 - 510k exempt.

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Common Device Name: UROLOGICAL CATHETER AND ACCESSORIES
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): VENUSA DE MEXICO S. DE R.L. DE C.V.; calle hertz 1525; parque industrial a j bermudez; ciudad juarez, chihuahua 32470 ; MX 32470
• Manufacturer Contact: victoria foss ; 340 hazeltine drive; chaska, MN 55318 ; 9526418506
• MDR Report Key: 14698291
• Report Number: 9680001-2022-00105
• Device Sequence Number: 5326990
• Product Code: EYA
• UDI-Device Identifier: 10816349011785
• UDI-Public: 10816349011785
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: M0066802081
• Device Lot Number: JRZ7005896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2022
• Supplement Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female