MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ISLEEVE 15F; INTRODUCER, CATHETER

Model Number 10445

Device Problems Break (1069); Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)

Patient Problem Blood Loss (2597)

Event Date 09/30/2020

Event Type  Injury  

Event Description

(b)(6) post market study.It was reported that a liner tear and blood loss occurred.Prior to the index procedure, heparin or other anticoagulant was not given and the subject was not on prior regimen of aspirin or any other antiplatelet medications at the time of index procedure.The subject received a loading dose of 300mg of aspirin.A 15f isleeve introducer sheath was placed and then the aortic valve was treated with balloon aortic valvuloplasty (bav).No conduction disturbance was noted post bav.A 27mm lotus edge valve was then deployed.There was correct positioning of the 27mm lotus edge valve into the proper anatomical location.The lotus edge delivery system was unable to be withdrawn through the 15f isleeve introducer sheath.When attempting to pull the lotus edge delivery system through the 15f isleeve introducer sheath, the tip of the 15f isleeve introducer sheath appeared to move back towards the proximal part of the sheath.The 15f isleeve introducer sheath and lotus edge delivery system were removed together as one unit, with resistance noted.The 15f isleeve introducer sheath was kinked and the inner liner was torn.Two non-bsc suture-mediated closure systems were deployed but considerable bleeding was present at the access site and so an additional two non- bsc suture-mediated closure systems and one non-bsc vascular closure device were used to achieve hemostasis.It was confirmed via imaging of the subjects leg, that the vessel was undisturbed and still had good flow.Post index procedure, electrocardiogram (ecg) revealed a new onset of left bundle branch block.The event led to prolongation of hospitalization.The subject was transferred to the coronary care unit and suggested to initiate with direct oral anticoagulation.Two days post procedure, the patient was discharged home on other anticoagulants.

Manufacturer Narrative

H3:device eval by manufacturer:the 15f isleeve introducer sheath was returned to boston scientific(bsc) and analyzed by a bsc quality engineer.Device analysis of the returned 15f isleeve sheath confirmed that one seam had a 13cm long tear starting 4.5cm from the distal tip.The tip is damaged and one tip seam is torn.All of the seams have expanded and there are numerous sheath kinks along the 15f isleeve device.

Event Description

Respond edge post market study.It was reported that a liner tear and blood loss occurred.Prior to the index procedure, heparin or other anticoagulant was not given and the subject was not on prior regimen of aspirin or any other antiplatelet medications at the time of index procedure.The subject received a loading dose of 300mg of aspirin.A 15f isleeve introducer sheath was placed and then the aortic valve was treated with balloon aortic valvuloplasty (bav).No conduction disturbance was noted post bav.A 27mm lotus edge valve was then deployed.There was correct positioning of the 27mm lotus edge valve into the proper anatomical location.The lotus edge delivery system was unable to be withdrawn through the 15f isleeve introducer sheath.When attempting to pull the lotus edge delivery system through the 15f isleeve introducer sheath, the tip of the 15f isleeve introducer sheath appeared to move back towards the proximal part of the sheath.The 15f isleeve introducer sheath and lotus edge delivery system were removed together as one unit, with resistance noted.The 15f isleeve introducer sheath was kinked and the inner liner was torn.Two non-bsc suture-mediated closure systems were deployed but considerable bleeding was present at the access site and so an additional two non- bsc suture-mediated closure systems and one non-bsc vascular closure device were used to achieve hemostasis.It was confirmed via imaging of the subjects leg, that the vessel was undisturbed and still had good flow.Post index procedure, electrocardiogram (ecg) revealed a new onset of left bundle branch block.The event led to prolongation of hospitalization.The subject was transferred to the coronary care unit and suggested to initiate with direct oral anticoagulation.Two days post procedure, the patient was discharged home on other anticoagulants.

• Brand Name: ISLEEVE 15F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10680175
• MDR Text Key: 211360676
• Report Number: 2134265-2020-13921
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0024647317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 12/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR