MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / MINI STICK MAX; DILATOR , VESSEL FOR PERCUTANEOUS CATHETERIZATION

Catalog Number	H965457581
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
While photos of the fractured guidewire have been provided the device sample has not yet been returned.The manufacturer of the guidewire, lake region manufacturing, will be involved in the event investigation.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported, "during a brachiocephalic fistula declot, when advancing the stainless/palladium wire, the palladium tip broke off and lodged in the patient's vasculature.The tip had to be snared percutaneously for retrieval.Photos have been provided and it has been indicted that the used wire will be returned, as well, for evaluation.
Additional Manufacturer Narrative
A no lot number was reported, a ship history report (shr) was generated for item number h965457581 in order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The three lots obtained through the shr were (5402157, 5408461 and 5419034).The device history records for the lots obtained through the ship history report (packaging lots) were reviewed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.A scar (supplier corrective action request) was sent to lake region manufacturing, the guidewire supplier.No sample was available, but their review of the guidewire lots corresponding with the ship history indicated that there was no "indication of a manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable." the (b)(6) 2019 angiodynamics complaint report was reviewed for the mini sticks product family and the failure mode "guidewire fractured/migrated." no adverse trend was indicated.The root cause for the reported event was unable to be determined from the information provided.The directions for use provided with the mini stick max kit caution that "excessive force against resistance" or withdrawing the guidewire through the needle could result in guidewire damage.(pr (b)(4)).

• Brand Name: ANGIODYNAMICS / MINI STICK MAX
• Common Device Name: DILATOR , VESSEL FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8367305
• Report Number: 1317056-2019-00041
• Device Sequence Number: 1915706
• Product Code: DRE
• UDI-Device Identifier: H965457581
• UDI-Public: H965457581
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K132713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: H965457581
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention