MAUDE Adverse Event Report: LEPU MEDICAL TECHNOLOGY (BEIJING) CO.,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  Injury  

Manufacturer Narrative

The lot number cannot be obtained and the relevant records cannot be checked.The lot number cannot be obtained and the retained samples investigation cannot be conducted.Current manufacturing products were tested instead.Test was conducted according to the ifu: injected 20ml (maximum volume) air.Deflated 2ml air two times successively.Checked the remained air volume.The test was conducted multiple times.A small amount of air leakage (less than 1ml in two deflation combined) was observed.The greater the pressure is, the more likely to leak air.It would not cause an extra air leakage during inflation and deflation process, but slow connection of syringe and single way valve would cause a small amount of air leak, so a quick action is suggested.Two products were returned back.It is suspected that the products were immersed in alcohol or other disinfectant for a long time.The product is wet and pink.An assessment was conducted on the returned product.20ml air was inflated into the product and kept the pressure.In the process, no leakage was found.After deflation, a few wrinkles were found on the surface of the balloon.The raw material has deteriorated, yet no leakage was found.No anomaly was found on the returned product.And no further information (i.E.Lot number, usage information) can be obtained.The root cause of this case cannot be confirmed.No corrective actions will be conducted for the moment.Feedbacks on similar cases would be paid close attention to.

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 3008002401-2020-00002.

Manufacturer Narrative

Inquired the distributor by mail: 1.Is it possible to send the products back or provide us the lot number? 2.Which specific position did the doctor place the proximal and distal vasc band? 3.In your description, the air inflated was around 15-20ml.Is there an exact volume of how much air is inflated? 4.The nurse released 5ml air of the proximal band, which is not coherent with the ifu.The ifu suggests to release 2ml air.How much air was firstly withdrawn of the distal band? 5.When bleeding was observed, did the nurse find the balloon became smaller? 6.How much air did the nurse withdraw in the end? did the nurse withdraw all the air? 7.Did the patient have diabetes, hypertension, etc.? 8.Which complication caused the patient's decease the nurse's reply was received on feb.22 2020: 1.The product was returned.I did not know the lot number.2.The distal band was placed over puncture site and the proximal band was placed approx.1cm above the distal band.3.In charting i charted up to 15ml of air, however that was very conservative charting.4.1 hour and 15min after the procedure, the patients hand was cool and dusky still and c/o some numbness and tingling so i release 5ml of air from the proximal band, and didn't adjust the distal band.At this point the site was stable.At two hours past end of procedure i attempted to release 2l of air from the distal band, and immediately saw bleeding and 2ml of air replaced.Our orders allow us to release 3-5ml at a time.5.Initially i didn't notice the balloon to be smaller, but as this played out over the next hours i did notice that the balloon didn't look as tight as it should for how much air was in it when i went back to check it.6.The proximal band had 5ml of air not accounted for, as well as the distal band.I continued to draw back to make sure i had all the air out of the band.7.Nstemi, cad, ckd, paf, dyslipidemia, grout, crohn's disease.8.The patient had complications with his ckd.Inquired the distributor by mail: 1.Why did the nurse use two compression tourniquets? 2.The nurse stated "our orders allow us to release 3-5ml at a time".Is this the hospital order? because it is quite different from our ifu suggested (2ml).Nurse's reply was received on feb.28th 1.The reason is not explained.2.This is per our physician's order.Inquired the distributor by mail: 1.Have you performed training to this hospital? is there any training record? 2.After this complaint, have you performed training to this hospital? any training record? the distributor replied on mar 25 has been utilizing vascband as far back as 2016 that we can see.It is believed that the prior sales representative covering (b)(6) provided training and in-servicing of this product, however, we do not have a training record.Due to the current circumstances surrounding the pandemic of covid-19 in the united states, sales representatives are not currently allowed in hospitals.Once these protocols are lifted the current sales representative, (b)(4), will follow-up with the account to provide in-servicing.At this point timing is undeterminable.Lepu medical replied on mar 25: let me know after you've provided the training and keep the record.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.

• Brand Name: VASC BAND
• Type of Device: HEMOSTAT
• Manufacturer (Section D): LEPU MEDICAL TECHNOLOGY (BEIJING) CO.,LTD; no.37 chaoqian road,; changping district; beijing, 10220 0; CH 102200
• MDR Report Key: 9735037
• MDR Text Key: 192653802
• Report Number: 3008002401-2020-00001
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K142359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Date Manufacturer Received: 03/25/2020
• 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