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

Model Number 3822

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the balloon leaked.A 10/4.00 flextome cutting balloon was selected for use.During the procedure, at first inflation, the physician found that the balloon was leaking gas when inflating.The balloon failed to inflate despite application of pressure and the contrast was leaking.The balloon was simply pulled out from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: 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.The device was attached to an inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located approximately 2mm proximal of the proximal markerband.The rated burst pressure for this device is 12 atmospheres.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip, markerbands or blades.All blades were present and fully bonded to the balloon surface.No kinks or damage were noted along the shaft of the device.No other issues were identified during the product analysis.

Event Description

It was reported that the balloon leaked.A 10/4.00 flextome cutting balloon was selected for use.During the procedure, at first inflation, the physician found that the balloon was leaking gas when inflating.The balloon failed to inflate despite application of pressure and the contrast was leaking.The balloon was simply pulled out from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.

• 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: 10733847
• MDR Text Key: 213010013
• Report Number: 2134265-2020-14683
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2021
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0025511186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 50