MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; GUIDEWIRE INTRODUCER

Catalog Number	H965914004001
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records was performed for the reported packaging lot for item number h965914004001 for any deviations related to the reported defect of the complaint.The review confirms that the lot met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the y-adaptor product family and the failure mode "seal compromised".No adverse trend was indicated.Based on the sample supplied from the customer, the customer's complaint for "improper seal (seal compromised) is confirmed.The tip of the introducer sheath protector was sealed in the closure seal area of the pouch causing the seal to become compromised.The root cause is that responsible employees did not seal the pouch correctly and properly visualize per angiodynamics' procedures.Packages are 100% visualized for this type of non-conformance and the employees who packaged the lot in question did not identify the non-conforming units during their inspection.In an effort to heighten awareness of the performance of our products in the field, recent complaints have been reviewed in a weekly meeting with the entire department.All employees associated with the issue have been retrained on the applicable packaging and inspection procedures.((b)(4)).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(4), in the distributor's warehouse a compromised pouch seal was found on a guidewire introducer pouch, thereby breaching sterility.The pouch had not been provided to a hospital and was returned to angiodynamics for evaluation.

• Brand Name: ANGIODYNAMICS
• Common Device Name: GUIDEWIRE INTRODUCER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8032170
• Report Number: 1317056-2018-00186
• Device Sequence Number: 1499250
• Product Code: LIT
• UDI-Device Identifier: H965914004001
• UDI-Public: H965914004001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K903606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2018

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: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: H965914004001
• Device Lot Number: 5373017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1