MAUDE Adverse Event Report: ANGIODYNAMICS, INC SOFTVU OMNIFLUSH ANGIOGRAPHIC CATHETER

Catalog Number	H787107322035
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned for evaluation was one softvu omniflush 5fx65cm.038 catheter.A visual review of the catheter noted that the tip was fractured and was received into 2 separate pieces.The device met all manufacturing dimensional specifications for this product.The customer's reported complaint description of the tip of the catheter fracture is confirmed.The defect was discovered prior to making patient contact.Due to an increase in complaints for this failure mode, capa (b)(4) was initiated to determine the root cause and implement a corrective / preventative action for this type failure.A design change for this product was implemented (b)(6) 2017.The reported lot for this complaint was manufactured prior to the design change implementation.A review of the device history records was performed for the reported 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.The instructions for use, which is supplied to the end user with this catalog number, contains a statement; "reshaping of catheter tip is not recommended.Physical damage to the catheter material can result when exposed to heat".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).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2018: during preparation for an angiographic procedure, it was reported the angiographic catheter tip fractured/broke off from the catheter shaft.The device was set aside and a new of the same was used to successfully complete the procedure.It was reported the patient was not harmed or injured by this event as the defective catheter had not been placed inside of the patient.The reported defective disposable device has been returned to the manufacturer for evaluation.

• Brand Name: SOFTVU OMNIFLUSH ANGIOGRAPHIC CATHETER
• Common Device Name: SOFTVU OMNIFLUSH ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7907025
• Report Number: 1319211-2018-00101
• Device Sequence Number: 1472618
• Product Code: DQO
• UDI-Device Identifier: H787107322035
• UDI-Public: H787107322035
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: H787107322035
• Device Lot Number: 5122055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1