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

Catalog Number H787107120065

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/27/2019

Event Type  Injury  

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 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.

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
• Type of Device: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 8893027
• MDR Text Key: 154560850
• Report Number: 1319211-2019-00076
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H787107120065
• UDI-Public: H787107120065
• Combination Product (y/n): N
• PMA/PMN Number: K112452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/27/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 07/27/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention