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

Catalog Number	H787137097035
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/31/2017
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 to angiodynamics on september 01, 2017: during a tipss procedure, the catheter tip broke off inside of the patient.The fragment was successfully removed via a snare.The device was removed and set aside.The procedure was completed with a new of the same device.The patient did not suffer any harm or injury due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was one soft-vu catheter.A visual review of the catheter noted that the tip was fractured, 1.3cm from the weld joint.The customer's reported complaint description of fracture is confirmed.A root cause for this event cannot be determined.Capa (b)(4) was initiated to determine the root cause and implement a corrective / preventative action for this type failure.A review of the device history records was performed for the 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 adverse 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; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6878973
• Report Number: 1319211-2017-00093
• Device Sequence Number: 1324838
• Product Code: DQO
• UDI-Device Identifier: H787137097035
• UDI-Public: H787137097035
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/23/2017

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 Catalogue Number: H787137097035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 10/24/2017
• 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