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

Model Number H749RB4250100

Device Problem Material Rupture (1546)

Patient Problems Intimal Dissection (1333); Perforation of Vessels (2135)

Event Date 05/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

Event Description

It was reported that balloon burst, vessel dissection and vessel perforation occurred.The target lesion was located in the mid to distal left circumflex artery (lcx).A 10/2.50 flextome¿ cutting balloon¿ was selected for use.During the procedure, the balloon was inflated initially at 6 atmospheres and second inflation was at 8 atmospheres; however, the balloon burst and contrast media leaked out.The physician then noted vessel dissection and vessel perforation of the mid to distal lcx.A non- bsc balloon was inflated for 60 seconds to seal the perforation and a non-bsc stent was deployed.No further patient complications were reported and the patient's condition was stable and no chest pain reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device was attached to an encore inflation unit, subjected to positive pressure and a balloon pinhole leak was identified in the mid-section of the balloon.The markerbands, blades and tip section of the device were visually and microscopically examined and no issues were noted with their profiles that could have potentially contributed to the complaint incident.A visual and tactile examination identified multiple hypotube kinks along of the device.This type of damage is consistent with excessive force being applied to the delivery system during device use.No other issues were identified during the product analysis.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 balloon burst, vessel dissection and vessel perforation occurred.The target lesion was located in the mid to distal left circumflex artery (lcx).A 10/2.50 flextome¿ cutting balloon¿ was selected for use.During the procedure, the balloon was inflated initially at 6 atmospheres and second inflation was at 8 atmospheres; however, the balloon burst and contrast media leaked out.The physician then noted vessel dissection and vessel perforation of the mid to distal lcx.A non- bsc balloon was inflated for 60 seconds to seal the perforation and a non-bsc stent was deployed.No further patient complications were reported and the patient's condition was stable and no chest pain reported.

• Brand Name: FLEXTOME¿ CUTTING BALLOON¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5703018
• MDR Text Key: 46694473
• Report Number: 2134265-2016-05405
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P950020
• 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: 05/30/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2018
• Device Model Number: H749RB4250100
• Device Catalogue Number: RB425010
• Device Lot Number: 18034667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2016
• Initial Date FDA Received: 06/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• 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