MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE HYDROPHILIC GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	M00146152B1
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: it was reported that after unpacking, it was noted that the aseptic package of the guidewire was not sealed.The device is expected to be returned before may 31st.There were no patient complications reported.
Additional 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.This product receives a 100% verification of the seal by the production operator after the completion of each seal.The quality control inspectors are required to verify seal width, seal location, seal integrity and pouch appearance.There is a second on-line inspection performed by production during boxing.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.At this time, it is not possible to assign a definitive root cause for the event as reported.If there is any further relevant information provided, a follow up medwatch report will be submitted.
Additional Manufacturer Narrative
This medwatch follow up report is being filed due to device return.As received, the specimen consisted of one-1 each hydro gw std an 180-035; returned within an unsealed original package, double-bagged within "zip-lock" style poly biohazard pouches.The focus of the analysis is on the packaging pouch.The specimen pouch presented no presence of a bottom seal.Neither the mylar nor tyvek films presented any evidence of heat sealer application.No other damage or inconsistencies are noted to the specimen at this time.Except where noted, the specimen device appears visually correct.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.This product receives a 100% verification of the seal by the production operator after the completion of each seal.The quality control inspectors are required to verify seal width, seal location, seal integrity and pouch appearance.There is a second on-line inspection performed by production during boxing.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.If there is any further relevant information provided, a follow up medwatch report will be submitted.
Additional Manufacturer Narrative
Correction follow-up: this medwatch follow up report is being filed to correct the mdr follow up 1 report filed 19-september 2023.Corrections: 1.This device is not a combination product.2.Section b4 was updated in follow up 1, not d4 as documented incorrectly in section h10 of follow up 1 for 9680001-2023-00105.

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• 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 lake hazeltine drive; chaska, MN 55318 ; 9526418506
• MDR Report Key: 16986997
• Report Number: 9680001-2023-00105
• Device Sequence Number: 15146585
• Product Code: DQX
• UDI-Device Identifier: 08714729754718
• UDI-Public: 08714729754718
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000011
• 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,Followup
• Report Date (Section B): 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2025
• Device Model Number: M00146152B1
• Device Catalogue Number: 41536
• Device Lot Number: JRZ7140464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 05/11/2023; 05/11/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 09/19/2023; 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 80 KG