MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY XXL? VASCULAR; DILATOR, ESOPHAGEAL

Model Number M001145100

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/07/2015

Event Type  Injury  

Event Description

It was reported that tip detachment, catheter removal difficulties and balloon tear occurred.Vascular access was obtained via the popliteal vein.The target lesion was located in the popliteal artery.Angiojet was used from the knee up to the bifurcation.Two wallstents were implanted in the left common iliac vein.A 4/5.8/75 xxl¿ vascular balloon catheter was selected and advanced to post dilate the lesion.Upon removal, it was noted that the balloon was caught in the junction where the stents overlapped.The physician pushed and pulled the device; however the device was not removed.The physician jerked the balloon free, and ripped the balloon material.It was then noted that about one centimeter of the distal tip of the balloon catheter broke off in the body.The physician was able to get the detached tip down to the popliteal and out of the vein and into the subcutaneous tissue.However, the tip could not be removed any further.The physician elected to leave the tip in the patient¿s body.Venogram was performed to insure blood flow was not compromised.A 9 fr sheath was pulled out of the vein.Hemostasis was achieved.The procedure was completed with this device.No further patient complications were reported and the patient¿s status was fine.On the following day, the physician had a vascular surgeon review the case and stated that the tip would probably encapsulate and no further attempts would be needed to remove the device.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr: the device was received inserted through an introducer sheath.An examination of the introducer sheath identified that it was kinked at the end of its strain relief.Exiting from the sheath was the distal end of the xxl device.An examination of the xxl identified that a complete circumferential tear with longitudinal tear had occurred in the balloon.The circumferential tear was located at 4cm distal to the proximal touch-up.A microscopic examination of the circumferential tear site identified a longitudinal tear in the balloon from the proximal transition zone to the site of the complete circumferential tear.The distal section of the balloon tear was not received and a break was evident in the shaft at 7cm distal to the distal edge of the proximal markerband.The distal section of the break including the tip and distal section of the balloon tear was not received for analysis.An examination of the break site in the shaft identified clear signs of excessive tensile force having been applied to the shaft.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that tip detachment, catheter removal difficulties and balloon tear occurred.Vascular access was obtained via the popliteal vein.The target lesion was located in the popliteal artery.Angiojet was used from the knee up to the bifurcation.Two wallstents were implanted in the left common iliac vein.A 4/5.8/75 xxl¿ vascular balloon catheter was selected and advanced to post dilate the lesion.Upon removal, it was noted that the balloon was caught in the junction where the stents overlapped.The physician pushed and pulled the device; however, the device was not removed.The physician jerked the balloon free, and ripped the balloon material.It was then noted that about one centimeter of the distal tip of the balloon catheter broke off in the body.The physician was able to get the detached tip down to the popliteal and out of the vein and into the subcutaneous tissue.However, the tip could not be removed any further.The physician elected to leave the tip in the patient¿s body.Venogram was performed to insure blood flow was not compromised.A 9 fr sheath was pulled out of the vein.Hemostasis was achieved.The procedure was completed with this device.No further patient complications were reported and the patient¿s status was fine.On the following day, the physician had a vascular surgeon review the case and stated that the tip would probably encapsulate and no further attempts would be needed to remove the device.

• Brand Name: XXL? VASCULAR
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4466442
• MDR Text Key: 5184027
• Report Number: 2134265-2015-00157
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2017
• Device Model Number: M001145100
• Device Catalogue Number: 14-510
• Device Lot Number: 0017435225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2014
• 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
• Treatment: STENT: TWO WALLSTENTS
• Patient Outcome(s): Other
• Patient Age: 71 YR