MAUDE Adverse Event Report: BIOLIFE, LLC STATSEAL DISC

Model Number DA628

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Skin Erosion (2075); Skin Inflammation/ Irritation (4545)

Event Date 12/28/2021

Event Type  Injury  

Event Description

On (b)(6) 2022 a doctor text a patient photo of a patient's right wrist with a ~2cm rounded wound where a radial sheath (right radial terumo slender glide 6x10 sheath) had been placed ((b)(6) 2021) for a diagnostic cardiac catheterization performed by a doctor.No acute patient distress was ever reported and hand circulation, motion and sensation (cms) have always been within normal limits.The wound did not have any observed or reported drainage.The dr.Also text a prior photo of the site ~36-48 hours post-procedure after the disc dressing had been removed showing relatively minor skin irritation at the same site.The patient was place on oral bactrim antibiotic with a referral to wound care on (b)(6) 2022.During a follow up office visit on (b)(6) 2022 the wound appeared to be improving and hand cms remain intact.Notably the patient was using his cane with his right hand per his usual.The wound is reportedly improving and photos from (b)(6) 2022 show reduced redness and swelling.

Manufacturer Narrative

Biolife's chief medical advisor documented an evaluation of the incident.

• Brand Name: STATSEAL DISC
• Type of Device: STATSEAL
• Manufacturer (Section D): BIOLIFE, LLC; 8163 25th court east; sarasota FL 34243
• Manufacturer (Section G): BIOLIFE, LLC; 8163 25th court east; sarasota FL 34243
• Manufacturer Contact: claudia masselink ; 8163 25th court east; sarasota, FL 34243 ; 9413601300
• MDR Report Key: 13501950
• MDR Text Key: 289874237
• Report Number: 1066421-2022-00001
• Device Sequence Number: 1
• Product Code: FRO
• UDI-Device Identifier: 00834061006202
• UDI-Public: 00834061006202
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DA628
• Device Catalogue Number: DA628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male