MAUDE Adverse Event Report: LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. VSI BAND; CLAMP, VASCULAR

Model Number 3524

Device Problem Air Leak (1008)

Patient Problem Hemostasis (1895)

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

Dhr was reviewed; testing has been performed on reserved samples and actual returned sample.However, root cause cannot be identified at present.

Event Description

After completing a radial access heart cath, the rt sheri applied the band and inflated the balloon to 17 mls.The patient was taken to the recovery floor and just prior to the first deflation, the balloon deflated completely causing a bleed.A new band was deployed and hemostasis was achieved.

• Brand Name: VSI BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.; no.37, chaoqian road,; changping district; beijing, 10220 0; CH 102200
• Manufacturer (Section G): LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.; no.37, chaoqian road,; changping district; beijing, 10220 0; CH 102200
• Manufacturer Contact: bo jiang ; no.37, chaoqian road; changping district; beijing, 10220-0 ; CH 102200 ; 1381034605
• MDR Report Key: 6408877
• MDR Text Key: 70067021
• Report Number: 3008002401-2017-00002
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2018
• Device Model Number: 3524
• Device Catalogue Number: N.A.
• Device Lot Number: 201604015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization