MAUDE Adverse Event Report: LEPU MEDICAL TECHNOLOGY LTD. VASC BAND; HEMOSTAT

Model Number 3524

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 01/03/2020

Event Type  Death  

Event Description

It was reported that the patient had a coronary angiogram with des to lad, lcx, and ptca to om1, on the right radial artery.Patient then came to the cath lab recovery with 2 vasc bands in place.On the 2nd hour mark, started to try to release air on the distal band, due to the patient's dusky hand, 5ml of air was released on the proximal band around 1 1/2 hours and that went fine.When releasing the distal bands air, the site immediately started bleeding and air was reinserted.Site looked good and then checked in 15, and it was bleeding.Air was reinserted and 20 min later the site was bleeding again, and air was reinserted.This went on for the next 1 1/2 hours but sometimes it was fine, other times it was bleeding.Other personnel checked on it.I should have had 15 -20 mls in each band but once i was able to start releasing air, i didn't get that much out.The only thing i could think of was when i released air somehow it created a leak in the band, so it was slowly leaking air and wasn't holding what it should be.There was no significant bleeding that required a second intervention.Additional information received on 15jan2020 is that the patient expired.Angiogram successful, however complications from cr rising lead to respiratory arrest and patient expired days later.Additional information received 23jan2020 states, the death was not associated to the vasc bands.Associated to mdr 2134812-2020-00008.

Event Description

It was reported that the patient had a coronary angiogram with des to lad, lcx, and ptca to om1, on the right radial artery.Patient then came to the cath lab recovery with 2 vasc bands in place.On the 2'nd hour mark, started to try to release air on the distal band, due to the patient's dusky hand, 5ml of air was released on the proximal band around 1 1/2 hours and that went fine.When releasing the distal bands air, the site immediately started bleeding and air was reinserted.Site looked good and then checked in 15, and it was bleeding.Air was reinserted and 20 min later the site was bleeding again, and air was reinserted.This went on for the next 1 1/2 hours but sometimes it was fine, other times it was bleeding.Other personnel checked on it.I should have had 15 -20 mls in each band but once i was able to start releasing air, i didn't get that much out.The only thing i could think of was when i released air somehow it created a leak in the band, so it was slowly leaking air and wasn't holding what it should be.There was no significant bleeding that required a second intervention.Additional information received on 15jan2020 is that the patient expired.Angiogram successful, however complications from cr rising lead to respiratory arrest and patient expired days later.Additional information received 23jan2020 states, the death was not associated to the vasc bands.Associated to mdr 2134812-2020-00008.

Manufacturer Narrative

Associated to: mdr 3008002401-2020-00001 and mdr 30080002402.Conclusion: no anomaly was found on the returned product.According to the information acquired form the nurse, the deflation process is not conducted according to the ifu.The patient's decease is not caused by the product.Since no evidence showed the product functioned unusually, no corrective actions will be conducted for the moment.Feedbacks on similar cases would be paid close attention to.Also, associated to: uf/importer report #: 2134812-2020-00008 and 2134812-2020-00007.

• Brand Name: VASC BAND
• Type of Device: HEMOSTAT
• Manufacturer (Section D): LEPU MEDICAL TECHNOLOGY LTD.; no 37 chaoqian road; changping district, 10220 0; CH 102200
• MDR Report Key: 9641249
• MDR Text Key: 176757496
• Report Number: 2134812-2020-00007
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 01/23/2020,01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Distributor Facility Aware Date: 01/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86 YR
• Patient Weight: 77