MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ISLEEVE 14F; INTRODUCER, CATHETER

Model Number H74939349140

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Torn Material (3024)

Patient Problems Intimal Dissection (1333); Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 05/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a seam tear, vessel damage, removal difficulty and bleeding occurred.Severe tortuosity was noted on the right femoral so vascular access was obtained via a left femoral approach; however, just before the aortic bifurcation there was also "kinking" noted on the left iliac.A 14f isleeve introducer sheath was inserted without resistance.A non-bsc extra stiff wire was used.The physician inserted and removed the aortic valvuloplasty balloon without any problem or resistance.An acurate tf delivery system and large acurate neo valve system were inserted into the isleeve and encountered a point where the physician felt a big resistance and could not go further with the system.Angio images revealed the isleeve was split and the delivery system did not follow the wire into the aorta.The wire was through the sheath and into the right iliac.One of the isleeve seams were torn.The physician believes it is possible the tear occurred while inserting the delivery system and trying to cross the kinking iliac just below the bifurcation.Due to the damaged isleeve and impossibility to go into the aorta, the decision was made to remove the sheath and delivery system with the valve loaded.The free cells on the loaded acurate neo did not allow the device to go through the arteriotomy.They tried to cut the sheath at the fold and insert it again to remove the delivery system and remaining sheath but it didn't help, the decision was made to remove the devices surgically.Just before the surgery and to prevent patient instability, a non-bsc valve was implanted via a right femoral approach.After successful implant of the non-bsc valve, the surgeons surgically removed the acurate neo valve and delivery system.During the operation, the patient had massive bleeding at the left femoral which was treated with the implant of a 12mm diameter and 8cm in length prosthesis.The patient also required cpr (cardiopulmonary resuscitation).After the procedure, the patient was stable.The patient is recovering well, and was transferred to curative treatment under good condition.Additional follow up indicated that since the event was reported, the patient is doing "very well" and has left the hospital.This product is only ous approved but it is similar to an approved us device.

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of a portion of an isleeve sheath.The sheath was microscopically examined.The hub and 86mm of the sheath was sent back.The distal portion of the sheath and tip were not returned.The sheath was cut by the customer 86mm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Product analysis confirmed the reported event due to the damage.The investigation conclusion is design specification as the device problem was traced back to the design specifications.(b)(4).

Event Description

It was reported that a seam tear, vessel damage, removal difficulty and bleeding occurred.Severe tortuosity was noted on the right femoral so vascular access was obtained via a left femoral approach; however, just before the aortic bifurcation there was also "kinking" noted on the left iliac.A 14f isleeve introducer sheath was inserted without resistance.A non-bsc extra stiff wire was used.The physician inserted and removed the aortic valvuloplasty balloon without any problem or resistance.An acurate tf delivery system and large acurate neo valve system were inserted into the isleeve and encountered a point where the physician felt a big resistance and could not go further with the system.Angio images revealed the isleeve was split and the delivery system did not follow the wire into the aorta.The wire was through the sheath and into the right iliac.One of the isleeve seams were torn.The physician believes it is possible the tear occurred while inserting the delivery system and trying to cross the kinking iliac just below the bifurcation.Due to the damaged isleeve and impossibility to go into the aorta, the decision was made to remove the sheath and delivery system with the valve loaded.The free cells on the loaded acurate neo did not allow the device to go through the arteriotomy.They tried to cut the sheath at the fold and insert it again to remove the delivery system and remaining sheath but it didn't help, the decision was made to remove the devices surgically.Just before the surgery and to prevent patient instability, a non-bsc valve was implanted via a right femoral approach.After successful implant of the non-bsc valve, the surgeons surgically removed the acurate neo valve and delivery system.During the operation, the patient had massive bleeding at the left femoral which was treated with the implant of a 12mm diameter and 8cm in length prosthesis.The patient also required cpr (cardiopulmonary resuscitation).After the procedure, the patient was stable.The patient is recovering well, and was transferred to curative treatment under good condition.Additional follow up indicated that since the event was reported, the patient is doing "very well" and has left the hospital.

• Brand Name: ISLEEVE 14F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7556631
• MDR Text Key: 109639447
• Report Number: 2134265-2018-04571
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2019
• Device Model Number: H74939349140
• Device Lot Number: 21896970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 07/25/2018
• Supplement Dates FDA Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2018
• 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: 81 YR