MAUDE Adverse Event Report: ANGIODYNAMICS MARINER HYDROPHILIC ANGIOGRAPHIC CATHETER; MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER,

Catalog Number H787117140255

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2017

Event Type  malfunction  

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 Description

As reported to angiodynamics on (b)(6) 2017: when placing the angiographic catheter, the cvt reported that when sliding the straightener off the catheter, the straightener sheered off the curved tip.It occurred during the prep of the catheter outside the patient prior to the start of the procedure.There was no patient contact with the catheter.The reported defective disposable device has been returned to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was one soft-vu catheter.A visual review of the catheter noted that the tip was fractured in four different locations.The customer's reported complaint description of the tip of the catheter sheered is confirmed.The defect was discovered prior to making patient contact.Although the complaint description is confirmed, a definitive root cause for the bent cannot be determined.Due to an increase in complaints for this failure mode, 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 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.Complaint # (b)(4).

Manufacturer Narrative

Returned for evaluation was one soft-vu catheter.A visual review of the catheter noted that the tip was fractured in four different locations.The id and od of the catheter tip were found to be within specification.The customer's reported complaint description of the tip of the catheter sheered is confirmed.The defect was discovered prior to making patient contact.Although the complaint description is confirmed, a definitive root cause for the bent cannot be determined.Due to an increase in complaints for this failure mode, capa (b)(4) was initiated to determine the root cause and implement a corrective / preventative action for this type failure.The corrective action was implemented in august 2017.The catheter in question was confirmed to have been manufactured prior to the corrective action.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.Complaint # (b)(4).

• Brand Name: MARINER HYDROPHILIC ANGIOGRAPHIC CATHETER
• Type of Device: MARINER HYDROPHILIC COATED 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 ; 10 glens falls technical park; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 7068039
• MDR Text Key: 93709455
• Report Number: 1319211-2017-00128
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H787117140255
• UDI-Public: H787117140255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2018

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: Medical Technologist
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: H787117140255
• Device Lot Number: 4825500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 11/14/2017; 11/14/2017
• Supplement Dates FDA Received: 03/26/2018; 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2015
• 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