MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION SILICONE CATHETERS; CATHETER, CHOLANGIOGRAPHY

Model Number 14228

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.

Event Description

Hospital reported that the chest x-ray did not show radiopaque line on the catheter.

Event Description

N/a.

Manufacturer Narrative

Analysis - as the device in question was not returned an x-ray evaluation of the product could not be conducted.Images from the case were provided and there were no signs of the radiopaque lines of the catheter in either of the x-ray images.A review of the complaint log going back a full 3 years shows that there has not been a complaint for the visibility of the radiopaque line of the catheter during this duration.During this 3 year time frame there has been 226,980 silicone thoracic catheters sold.As the device in question was not returned a group of silicone catheters recently received from the oem vendor (degania medical) were evaluated to determine if the radiopaque lines were visible under x-ray.They were of the same finished good part number 14024 and were from lot number 447900.The total of 6 samples were brought to an independent laboratory (microvision laboratories).The results of this x-ray were that all 6 samples when placed under x-ray the radiopaque lines were clearly visible.The vendor who supplies the silicone catheters (degania medical) also tested 5 samples from their retain inventory of manufacturing lots created for atrium medical.Degania medical tested 5 samples total.One sample each from the following batches: d1839990, d1900046, d1928162, d1930006, d1935453.The 5 samples were evaluated by sending the samples to x-ray at the poriya hospital in israel.The radiopaque line was able to be clearly seen during this inspection of each catheter in question.The retained lot samples tested by degania medical were chosen as they are all recent lots of silicone catheters received by atrium medical.In all cases the line on the catheters were easily seen during x-ray.Summary/conclusion - based on the details provided with the complaint, lack of a product lot number or physical product in question atrium medical corporation cannot conclude that the device was faulty.All x- ray imaging conducted on recent production lots indicate that the radiopaque line is highly visible.H3 other text : device not returned.

• Brand Name: SILICONE CATHETERS
• Type of Device: CATHETER, CHOLANGIOGRAPHY
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9767171
• MDR Text Key: 186839991
• Report Number: 3011175548-2020-00332
• Device Sequence Number: 1
• Product Code: GBZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 14228
• Device Catalogue Number: 14228
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1