MAUDE Adverse Event Report: TELEFLEX ARROW SUPER ARROW FLEX 7 FR INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number CP-07711

Device Problem Insufficient Information (3190)

Patient Problem Ischemia (1942)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

Prytime is reporting this mdr because it provides a convenience kit with a 7 fr introducer sheath to the user facility.Prytime medical is listed as the legal manufacturer of the convenience kit by virtue of its role as a repackager.The items within the kit are supplied in their original sealed oem packaging.The 7 fr introducer sheath included in this convenience kit is manufactured by teleflex, inc.It is unknown if this sheath was used in this case.The reporting physician, dr.(b)(6) communicated that uams has performed approximately 18 reboa procedures in high-risk obstetrics patients prior to 2020 without experiencing issues.Since the start of the year, they have performed 3 reboa procedures, 2 of which they experienced complications related to the introducer sheath.Two notable differences associated with the cases performed in 2020 are: dr.(b)(6), the trauma surgeon who was previously called upon to physically deploy the er-reboa catheter in high-risk obstetrics patients is no longer working at uams.The practice for high-risk obstetrics patients at uams has shifted from prophylactic deployment of the er-reboa catheter to prophylactic deployment of a 5 fr.Micro catheter, which would be upsized to a 7 fr.Introducer sheath to deploy the er-reboa catheter if necessary.In response to the issues experienced, dr.(b)(6) reported that uams is reverting to the practice of prophylactic deployment of the er-reboa catheter instead of the 5 fr.Micro catheter for high-risk obstetrics patients.Prytime is also working with uams to schedule additional on-site training.

Event Description

5 fr micro catheter was placed prophylactically in the cfa of an obstetric patient known to be at high-risk of hemorrhage.Patient became hypotensive and the decision was made to upsize to a 7 fr introducer sheath and place the er-reboa catheter emergently to control hemorrhage.This occurred during manual compression of the aorta as a means of temporary hemorrhage control.Once the er-reboa catheter was deployed, the physician decided it was not needed and the balloon was not inflated.Patient ended up with no pulse in one of their legs and a vascular consult was required.The vascular surgeon suggested that the 7 fr introducer sheath may have been too large or occlusive for the patient's common femoral artery.Ultimately the patient survived and the leg was saved.Other facts and details of the case are unknown.

• Brand Name: ARROW SUPER ARROW FLEX 7 FR INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX
• Manufacturer (Section G): PRYTIME MEDICAL DEVICES, INC.; 229 north main street; boerne, tx
• Manufacturer Contact: brian young ; 229 n main street; boerne, tx ; 3400116
• MDR Report Key: 9892165
• MDR Text Key: 195952439
• Report Number: 3012279212-2020-00003
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970229
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CP-07711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1