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

Catalog Number	H787107120065
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/27/2019
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.Complaint # (b)(4).
Event or Problem Description
As reported: dr.(b)(6) was in a gi bleed case.During the procedure, it was noted the sos 2 catheter tip dislodged/detached from the shaft of the catheter in the gastric artery.The device and fragment were removed and the procedure was completed with a new of the same device.They saved the sos tip that malfunctioned to return to the manufacturer for evaluation.There was no permanent harm or injury to the patient, and the patient was reported as stable post procedure.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was the catheter tip end, the remaining catheter tubing was not returned.Per the manufacturing engineer for this product, "the failure mode is consistent with tip embrittlement associated with a capa, which added heat/light stabilizers to the soft-tip material (closed in august of 2017).Processing of this catheter commenced prior to implementation of the soft tip material change." the customer's reported complaint description of "the catheter tip dislodged from the catheter "is confirmed.The root cause for the detached tip was the material used in the manufacturing of this device lot.A material change to address the robustness of the catheter tip was implemented on (b)(6) 2017.The catheter assemblies associated with packaging lot 5480648 were manufactured before the implementation of this material change.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.(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: 8893027
• Report Number: 1319211-2019-00076
• Device Sequence Number: 1505067
• Product Code: DQO
• UDI-Device Identifier: H787107120065
• UDI-Public: H787107120065
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

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: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: H787107120065
• Device Lot Number: 5070633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2019
• Supplement Date Received by Manufacturer: 07/27/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 11/15/2019
• 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