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

Model Number 3822

Device Problem Material Rupture (1546)

Patient Problems Chest Pain (1776); Chest Tightness/Pressure (2463); Vascular Dissection (3160)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the balloon burst and lead to vessel dissection.Vascular access was obtained utilizing retrograde approach.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified mid left anterior descending artery (lad).A 10/2.50 flextome cutting balloon was selected for use.During the procedure, the balloon burst upon second inflation at 6atm causing a type b, blood flow limiting dissection from lad to left main trunk (lm).Consequently, symptoms like chest pain and chest tightness were observed on the patient.The balloon was then generally removed and a 3.0mmx30mm drug-eluting stent was used to treat the dissection.No further complications were reported and the patient is stable.

Event Description

It was reported that the balloon burst and lead to vessel dissection.Vascular access was obtained utilizing retrograde approach.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified mid left anterior descending artery (lad).A 10/2.50 flextome cutting balloon was selected for use.During the procedure, the balloon burst upon second inflation at 6atm causing a type b, blood flow limiting dissection from lad to left main trunk (lm).Consequently, symptoms like chest pain and chest tightness were observed on the patient.The balloon was then generally removed and a 3.0mmx30mm drug-eluting stent was used to treat the dissection.No further complications were reported and the patient is stable.

Manufacturer Narrative

Initial reporter address: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and lumen which is evidence of a device leak.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied to inflate the balloon.The balloon could not be inflated due to the presence of solidified media that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the media before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device and subjected to positive pressure to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located approximately in the middle of the proximal markerband.A visual and microscopic examination observed no damage to the blades.All blades were present and fully bonded to the balloon surface.No damage or issues were noted with the blades that could have contributed to the complaint incident.The tip section of the device was visually and microscopically examined, and no issues were noted with its profile that may have potentially contributed to the complaint incident.A visual and microscopic examination found no issue with the profile of the device's markerbands which may have contributed to the complaint incident.A visual and tactile examination found no kinks or damage on the shaft of the device.No other issues were identified during the product analysis.

• Brand Name: FLEXTOME CUTTING BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8956939
• MDR Text Key: 156339632
• Report Number: 2134265-2019-10403
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0023341859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR