MAUDE Adverse Event Report: ANGIODYNAMICS MICRO INTRODUCER KIT; STANDARD MICRO INTRODUCER KIT,

Catalog Number	H787065970315
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint reference (b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(4) 2017: during an unknown procedure, the microintroducer guidewire came apart at the tip (unraveled) prior to insertion into the needle.The device was set aside and a new of the same device was used to successfully complete the procedure.There was no harm or injury to the patient as the device.It was reported the defective disposable device is not available for return to the manufacturer.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of guidewire coming apart cannot be confirmed as the sample was not returned for evaluation.Without doing a device evaluation, a definitive root cause for the reported complaint description cannot be determined.A review of the lot history records was performed for the reported packaging and incoming component lot for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.The guidewire is a purchased component.Angiodynamics' vendor was made aware of this complaint per (b)(4).As stated in the vendor's response: "although the exact root cause of the event is unable to be determined, it does not appear to be the result of manufacturing".The instructions for use, which is supplied to the end user with this catalog number instructs the user to withdraw the needling while leaving the guidewire in place.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: MICRO INTRODUCER KIT
• Common Device Name: STANDARD MICRO INTRODUCER KIT,
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6879085
• Report Number: 1319211-2017-00094
• Device Sequence Number: 800591
• Product Code: DQY
• UDI-Device Identifier: H787065970315
• UDI-Public: H787065970315
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K051655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

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: 07/31/2020
• Device Catalogue Number: H787065970315
• Device Lot Number: 5224424
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1