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

Catalog Number 13709803

Device Problems Detachment Of Device Component (1104); Device Issue (2379)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 04/12/2016

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has been returned to the manufacturer for a device evaluation.The results of the device evaluation will be sent via a follow up medwatch.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.Complaint # (b)(4).

Event Description

As reported (b)(6) 2016, a (b)(6), male patient presented for an angiographic procedure.During the case, after the angiographic catheter had been placed, the strain relief detached and slid down the catheter shaft and into the insertion site.The strain relief was removed with no complications or patient effect.The catheter was removed and set aside.A new of the same was used to successfully complete the procedure.There was no harm or injury to the patient due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was a accu-vu catheter.The hub was not received for evaluation.A visual review of the catheter noted that the hub was missing and the strain relief falls loosely along the shaft of the device.The material at the end of the shaft, where the hub is attached, appears stretched.The customer's reported complaint description of the strain relief detaching is confirmed.A definitive root cause for the reported complaint description cannot be determined, although it does not appear to be manufacturing related.During the sample analysis, the portion of the shaft where the strain relief is molded to the hub processes damage that could have been caused by excessive force or torque.Though it cannot be definitely determined, the most likely cause to this complaint is due to handling techniques during the procedure.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.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: ACCU-VU SIZING 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 ; 5187981215
• MDR Report Key: 5662540
• MDR Text Key: 45429804
• Report Number: 1319211-2016-00080
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H787137098035
• UDI-Public: H787137098035
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 13709803
• Device Lot Number: 4921673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2015
• 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
• Patient Age: 73 YR