MAUDE Adverse Event Report: ANGIODYNAMICS, INC SOFT-VU SIZING ANGIOGRAPHIC CATHETER; SOFT-VU SIZING ANGIOGRAPHIC CATHETER,

Catalog Number	H787107120045
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/23/2018
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.(b)(4).
Event or Problem Description
As reported to angiodynamics on march 23, 2018: during an angiographic procedure, it was noted the tip of the angiographic catheter had fractured off inside of the patient.The tip was successfully removed.It was reported the patient suffered no permanent harm or injury due to this event, it was reported the defective disposable device is not available for return to the manufacturer as it was disposed of by the user.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.However, based on photographs provided by the user, the customer's reported complaint description of a tip fracture is confirmed.Although the complaint description is confirmed, a defintive root cause cannot be determined as there was no device evaluation performed.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 the following statements: potential adverse effects: emboli, death.Warnings: never advance or retract an angiographic catheter or guidewire against resistance.This may result in damage to the vessel, the product, or both.Reshaping of catheter tip is not recommended.Physical damage to the catheter material can result when exposed to heat.Do not leave curved tipped catheters straightened over guidewires for extended periods of time.This will result in failure of the catheter tip to re-form to its intended shape.Always use a guidewire to remove the catheter from the vasculature.Failure to do so may result in damage to the vessel, puncture site, product, or all three.When retracting catheters, great care must be taken to avoid exerting excessive pressure at the groin entry site.Excessive pressure may result in damage to the vessel, the catheter, or both.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: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• Common Device Name: SOFT-VU SIZING ANGIOGRAPHIC CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7411789
• Report Number: 1319211-2018-00035
• Device Sequence Number: 16514486
• Product Code: DQO
• UDI-Device Identifier: H787107120045
• UDI-Public: H787107120045
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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: 11/30/2018
• Device Catalogue Number: H787107120045
• Device Lot Number: 4962379
• 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: 03/23/2018
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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