MAUDE Adverse Event Report: BOSTON SCIENTIFIC IRELAND LIMITED 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number 24628

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 07/24/2018

Event Type  Injury  

Event Description

It was reported that the vessel ruptured and intervention was done. The 90% stenosed target lesion was located in the moderately tortuous forearm shunt. A 6. 00mm/50cm 2cm peripheral cutting balloon was selected for use. During procedure, dilatation was performed for five times and each dilatation pressure was at 10atm. When it was raised to 7atm during fourth dilatation, the pressure decreased but it can be increased up to 10atm. Upon removal of the balloon, a fluoroscopy was performed and confirmed a rupture of blood vessel at the treatment area. The diameter of the vessel was determined via angiography as center: 6mm, near. Anastomosis site: 5mm, length of the lesion was 6cm. The bleeding was tried to stop with a balloon but failed. A surgical patch angioplasty was then performed and was able to stop the bleeding. Per physician's opinion, it was possible that the size of cutting was big which caused the vessel perforation. After dilatation was completed, the balloon was removed from the patient's body and was checked. It was further noted that the blade peeled off after the device was removed from the sheath; and, there was no severe resistance felt. The detached blade was not found even though it was searched inside the vessel and inside the sheath; the location was unknown. No further patient complications were reported and patient's status was normal/good.

Event Description

It was reported that the vessel ruptured and intervention was done the 90% stenosed target lesion was located in the moderately tortuous forearm shunt. A 6. 00mm/50cm 2cm peripheral cutting balloon was selected for use. During procedure, dilatation was performed for five times and each dilatation pressure was at 10atm. When it was raised to 7atm during fourth dilatation, the pressure decreased but it can be increased up to 10atm. Upon removal of the balloon, a fluoroscopy was performed and confirmed a rupture of blood vessel at the treatment area. The diameter of the vessel was determined via angiography as center: 6mm, near anastomosis site: 5mm, length of the lesion was 6cm. The bleeding was tried to stop with a balloon but failed. A surgical patch angioplasty was then performed and was able to stop the bleeding. Per physician's opinion, it was possible that the size of cutting was big which caused the vessel perforation. After dilatation was completed, the balloon was removed from the patient's body and was checked. It was further noted that the blade peeled off after the device was removed from the sheath; and, there was no severe resistance felt. The detached blade was not found even though it was searched inside the vessel and inside the sheath; the location was unknown. No further patient complications were reported and patient's status was normal/good. The device was returned for analysis. A visual and microscopic examination was performed on the returned device. It was noted that one of the blades was completely detached together with approximately 18mm of blade pad. Approximately 2mm of blade pad remained fully bonded to the balloon surface. The fully detached blade and blade pad were not returned for analysis. A section of another of the blades approximately 3mm in length was partially detached from the proximal end of the balloon material. The remaining section of blade and measuring approximately 17mm in length and the entire blade pad remained undamaged and fully bonded to the balloon material. The entire 2cm of blade was accounted for. All other blades were intact and fully bonded to the balloon material. A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure. The returned device was attached to an encore inflation unit. Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 1mm proximal of the distal markerband. An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint. No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident. A visual and tactile examination identified no kinks or damage to the shaft of the device. No other issues were identified during the product analysis.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC IRELAND LIMITED; EI
• MDR Report Key: 7797962
• MDR Text Key: 117616311
• Report Number: 2134265-2018-60215
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/29/2019
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0021445190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 08/20/2018 Patient Sequence Number: 1