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

Catalog Number	H787107327015
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/30/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 5976415
• Report Number: 1319211-2016-00137
• Device Sequence Number: 10871316
• Product Code: DQO
• UDI-Device Identifier: H787107327015
• UDI-Public: H787107327015
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K032376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: H787107327015
• Device Lot Number: 5070828G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2016
• Supplement Report FDA Received Date: 01/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1