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 Problems Hematoma (1884); Swelling (2091)

Event Date 08/18/2017

Event Type  Injury  

Manufacturer Narrative

Device was not returned for investigation.The device was reported as discarded.Requested lot number, however, not available.

Event Description

During my visit on the (b)(6) that after 7 pm on (b)(6) an octogenarian female was sent to cv step down following a diagnostic heart cath with dr., a vascband had been applied.According to the cv step down nurses charting the vascband was managed per hospital protocol.Documentation indicated that during the initial air withdrawal process air was reintroduced and per procedure gradually withdrawn.The vascband was documented to have been removed at 11 pm.At some point following the documented removal of the vascband a coband dressing was applied.24 hours following the documented removal of the vascband dr.Was consulted along with plastic surgery to address a claw like hand with dorsal swelling of the hand, suspected compartment syndrome.The patient underwent surgery.Dr.'s notes indicate that a pneumatic plastic dressing was under the coband dressing.I was informed that the patient was discharged and transferred to facility for physical rehabilitation.Additional information received (b)(6) 2017: confirmed with the rn in cv step down that they removed the vascband, that it was in fact removed at 11pm as charted and not reapplied later.Lot number not available and the vascband was discarded.No abnormality was reported.Hematoma formed after initial device removal.Manual pressure was applied and the vascband was reapplied.No hematoma noted after final removal.Vascband was applied in the cath lab at 7 pm - at 8:30 pm 5cc's of air was removed from the vascband - at 9:00 pm 4cc's of air was removed from the vascband.At 9:30 pm a hematoma developed, manual pressure was applied then the vascband was reapplied and inflated to 10cc.At 9:45 pm 4 cc's of air removed from the vascband - 10:00 pm 3 cc's of air removed from the vascband - 10:30 3 cc's of air removed from the vascband - 11:00 pm vascband removed.

• Brand Name: VASC BAND
• Type of Device: HEMOSTAT
• Manufacturer (Section D): LEPU MEDICAL TECHNOLOGY LTD.; 3rd floor, beikong science; 10 baifuquan road changping; beijing, 10220 0; CH 102200
• MDR Report Key: 6878357
• MDR Text Key: 86704287
• Report Number: 2134812-2017-00071
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2017

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?: No
• Device Operator: Physician
• Device Model Number: 3524
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/24/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 58