MAUDE Adverse Event Report: ANGIODYNAMICS GUIDEWIRE

Catalog Number	H787058001135
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2018: during an angiographic catheterization procedure, it was noted the guidewire appeared to become "frayed".The device was removed and set aside.The procedure was completed using a new of the same device.There was no patient harm or injury due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was one guidewire.A visual review of the returned device noted what appeared to be biological matter.The guidewire coil appeared to be stretched.The supplier of this device was notified of the event via (b)(4).The sample was forwarded to the supplier for a device evaluation and root cause determination.The customer's reported complaint description of the guidewire unraveling is confirmed.Per the supplier's response, "the physical analysis is unable to determine the cause of failure, however foreign mass is likely a contributing factor of the coil stretching".The supplier's review of the device's manufacturing records noted no deviations or observations at the time of manufacture.Although it is confirmed the supplier states "the physical analysis is unable to determine the cause of failure; however foreign mass is likely a contributing factor of the coil stretching".A review of the lot history records was performed for packaging lot (pl01417) for catalog number h787058001135 for any deviations related to the reported defect of the complaint.The review confirmed that the packaging lots and all component lots met all material, assembly, and performance specification.The instructions for use, which is supplied to the end user with this catalog number (sp-3363) inspect the guidewire prior to use for tip shape, bends, kinks or coil separation.Do not use if damaged.Using sterile technique, localize and puncture the vessel with a needle cannula.Remove the needle, leaving the cannula in place.Insert distal end of the guidewire through the cannula and into the vessel.Remove cannula, leaving guidewire within the lumen of the vessel.Pass the catheter over the guidewire within the lumen of the vessel under fluoroscope guidance to the desired position.Carefully remove the guidewire from the catheter.Excessive force against resistance may result in damage to guidewire and catheter or vessel perforation.Angiodynamics does not recommend a particular technique for the use of this device.The steps contained in the preceding directions discuss the seldinger technique for percutaneous entry and are for information purposes only.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint reference (b)(4).

• Brand Name: GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7334815
• Report Number: 1319211-2018-00028
• Device Sequence Number: 10860706
• Product Code: DQX
• UDI-Device Identifier: H787058001135
• UDI-Public: H787058001135
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K890207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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: Physician
• Device Expiration Date: 10/08/2020
• Device Catalogue Number: H787058001135
• Device Lot Number: PL01417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1