MAUDE Adverse Event Report: CREAGH MEDICAL SUBLIME RADIAL ACCESS GUIDE SHEATH; INTRODUCER, CATHETER

Model Number SRA-GS35-6F120

Device Problems Break (1069); Fluid/Blood Leak (1250); Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

Hub cap on the proximal hub of sheath became detached during high pressure injections.The physician applied 600 psi pressure injection using power injector (off label use) causing the cap on the proximal hub to become detached.The physician indicated he was able to put his thumb over the sheath and was able to continue the procedure with a small amount of leakage, no adverse event or outcomes observed.

Event Description

Surmodics' customer service received call from sales representative.Sales representative reports he was present during case on (b)(6) 2022 when guide sheath hub came loose from the sheath.During the procedure, the physician crossed the legion (left radial) and when an attempt was made to do a 600 psi injection, using power injection, the hub cap came off at the very distal end that snaps in place.Using power injection is indicated under the precautions section of the sublime guide sheath ifu, describing excessive leakage as a possible outcome.(b)(4).The physician was able to hold his thumb on the sheath and was able to continue with the procedure with small amount of leakage and no adverse events or other patient injury was observed.

Event Description

Follow-up report to submit additional information not known at time of initial submission.

• Brand Name: SUBLIME RADIAL ACCESS GUIDE SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway, ireland ; EI
• Manufacturer (Section G): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway, ireland ; EI
• Manufacturer Contact: holly ramirez ; 7905 golden triangle drive; eden prairie, MN 55344
• MDR Report Key: 13981065
• MDR Text Key: 298223283
• Report Number: 3014687026-2022-00002
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2024
• Device Model Number: SRA-GS35-6F120
• Device Lot Number: 22100175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2021
• 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