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

Catalog Number H787107327015

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).Device has not been returned to date.

Event Description

As reported (b)(6) 2016, when the product was received at the medical facility and removed from the shipping packaging, it was noted the inner sterile packages had small pinholes in the packaging.There was no patient contact as the defect was noted when received at the medical facility.It was reported the defective disposable device is available for return to the manufacturer for evaluation.

Manufacturer Narrative

The customer's reported complaint description of damaged packaging could not be confirmed because no sample was returned for evaluation.A lot history records search revealed no quality related issues or manufacturing deficiencies at the time of manufacture.During the boxing process, operators are attentive to abnormalities including damage to the pouch/box.Without receiving product to evaluate, a root cause cannot be determined although a possible contributing factor could be attributed to handling after the product left the angiodynamics facility.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).Device unavailable for return.

• Brand Name: SOFT-VU KUMPE ANGIOGRAPHIC CATHETER
• Type of Device: ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 5976415
• MDR Text Key: 55578011
• Report Number: 1319211-2016-00137
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H787107327015
• UDI-Public: H787107327015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: H787107327015
• Device Lot Number: 5070828G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1