MAUDE Adverse Event Report: ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETER

Catalog Number	H787107120085
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/18/2016
Type of Reportable Event	Serious Injury
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 (b)(6) 2016, a patient of unknown age and gender presented for an angiographic procedure.During the procedure, when the treating physician was trying to place a sos omni catheter through a sheath and the sos omni snapped in the middle of the shaft.The physician reported that he was in the aorta and might have torqued the catheter a little too hard, thus making it user error, but did say that it was strange.He was able to remove the catheter and reported the patient was not affected.The device was set aside and a new of the same was used to successfully complete the procedure.There was no harm or injury to the patient due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a 5f soft-vu catheter.A visual review of the device noted that 47 cm from the hub, the catheter is fractured.The shaft appears twisted at the site of the fracture the customer's reported complaint description of soft-vu fracturing is confirmed.A review of the lot 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 event description states that excessive torquing may have contributing to the fracture.The evidence presented on the returned sample supports this claim.The root cause is most likely do to user error.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.(b)(4).

• Brand Name: SOFT-VU ANGIOGRAPHIC CATHETER
• Common Device Name: ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6178527
• Report Number: 1319211-2016-00165
• Device Sequence Number: 914693
• Product Code: DQO
• UDI-Device Identifier: H787107120085
• UDI-Public: H787107120085
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112452
• 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): 03/18/2017

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: Physician
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: H787107120085
• Device Lot Number: 5047977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 03/16/2017
• 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