MAUDE Adverse Event Report: MICROVENTION, INC. CHAPERON GUIDING CATHETER SYSTEM (6F)

Model Number GC695M2VT

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to the manufacturer; it was forwarded to terumo, as they are the actual device manufacturer.The investigation of the device and a review of the lot information is underway.

Event Description

It was reported that the inner packing bag containing the sterile device was unsealed for a length of approximately 5 cm.The device issue was discovered in the warehouse prior to distribution to a customer facility.

Manufacturer Narrative

Prior to shipment of the device to the manufacturer, two photographs were provided of the device, which demonstrated a 5cm open pouch seal at the side, exposing the device within the pouch.The device was received for evaluation at the manufacturing facility on june 16, 2019.The results of the product investigation have not yet been provided.

Manufacturer Narrative

Review of the device history record and product release decision control sheet of the involved product/lot# confirmed that there were not any indications of anomalies.A search of complaint files did not find any similar report with the involved product/lot# combination.Visual inspection upon receipt found that the peel pack had an opening approx.60mm in length on the location around the hub of the inner catheter packed in the peel pack, where the film had been separated from the nonwoven fabric.There was not any other anomaly, such as a break or separation of the materials, on the remainders of the peel pack.The inner surfaces of the separated film and nonwoven fabric were electron microscopically inspection.On the surface of the film some transcribed fiber patterns of the nonwoven fabric were noted.The nonwoven fabric was found to have the evidence of adhesive applied there.These states were confirmed to be comparable to those of the separated film and nonwoven fabric of a current peel pack sample.The sealing strength of the actual peel pack sample was confirmed to meet the specification.A test to reproduce the issue was conducted.The difference in the atmospheric pressure during the transportation being taken into consideration, a test sample from the involved product code/lot# combination was inflated by applying an air pressure inside the peel pack and put into the unit box.This sample was then exposed to shock force by dropping a load on it.As the result, an opening was generated on the location around the hub of the inner catheter packed in the peel pack, where the film had been separated from the nonwoven fabric.The state was confirmed to be very similar to that of the actual sample as one of the possibilities, the following scenario can be inferred: due to the difference in the atmospheric pressure during transportation to the warehouse, the peel pack of the actual sample became swollen inside the unit box.In this state, the actualsample was subjected to shock force which exceeded the sealing strength of the peel pack, resulting in the generation of the opening.From the available information, however, it is difficult to determine the cause of this complaint definitely.

• Brand Name: CHAPERON GUIDING CATHETER SYSTEM (6F)
• Type of Device: GUIDING CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8714695
• MDR Text Key: 148540433
• Report Number: 2032493-2019-00155
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00810170013157
• UDI-Public: (01)00810170013157(11)180528(17)210430(10)180528
• Combination Product (y/n): N
• PMA/PMN Number: K082385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2021
• Device Model Number: GC695M2VT
• Device Catalogue Number: GC695M2VT
• Device Lot Number: 180528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1