MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SMALL PERIPHERAL CUTTING BALLOON¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number M001BPM4015140F0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 09/06/2016

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that patient suffered vascular tear.A 4.00mm x 1.5cm x 140cm small peripheral cutting balloon¿ was selected for arteriovenous fistula balloon dilatation.During the procedure when the balloon was advanced to the target location and was fully dilated, it was noticed that the contrast agent leaked.Subsequently, the physician decided to withdraw the device and a vascular tear was found through angiography.When the physician tried to insert the device again, it could not cross the location where the tear occurred.The physician used an unspecified balloon catheter to reach the torn vascular, then dilated the balloon and keep the balloon expanded around 10 minutes.After that, there was no further bleeding of the torn vascular.The procedure was completed with another of the same device.No further patient complications were reported and the patient's status is stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the catheter identified that the hypotube was kinked at various locations along its length.These kinks are consistent with excessive force having been applied to the device.No issues were noted with the distal extrusion.A microscopic examination of the balloon material identified no tears or damage along the balloon.A build-up of solidified contrast media was present inside the balloon.No damage was noted to the markerbands or blades.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that patient suffered vascular tear.A 4.00mm x 1.5cm x 140cm small peripheral cutting balloon¿ was selected for arteriovenous fistula balloon dilatation.During the procedure when the balloon was advanced to the target location and was fully dilated, it was noticed that the contrast agent leaked.Subsequently, the physician decided to withdraw the device and a vascular tear was found through angiography.When the physician tried to insert the device again, it could not cross the location where the tear occurred.The physician used an unspecified balloon catheter to reach the torn vascular, then dilated the balloon and keep the balloon expanded around 10 minutes.After that, there was no further bleeding of the torn vascular.The procedure was completed with another of the same device.No further patient complications were reported and the patient's status is stable.

• Brand Name: SMALL PERIPHERAL CUTTING BALLOON¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6090884
• MDR Text Key: 59552915
• Report Number: 2134265-2016-09911
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2019
• Device Model Number: M001BPM4015140F0
• Device Catalogue Number: BPM4015140F
• Device Lot Number: 0019024630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2016
• 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