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

Model Number 3822

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual and tactile examination found that the hypotube was completely separated and detached approximately 190mm from strain relief.There were multiple kinks identified along the hypotube shaft most noticeably near the break site on the distal section of shaft.It was identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.It is not known when the balloon was subjected to positive pressure.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the blades or visible pinholes in the balloon material.All blades were present and fully bonded to the balloon surface.Leak testing could not be performed to test for a balloon rupture due to the poor condition of the returned device.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 20nov2019.It was reported that the balloon could not inflate.The 90% stenosed, 20 mm x 5 mm target lesion was located in a mildly tortuous and severely calcified right coronary artery.A 10/2.75 flextome cutting balloon was selected for use to posy dilate an implanted stent.The balloon could not be inflated.The procedure was completed with another of the same device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that the hypotube was completely separated and detached.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9395803
• MDR Text Key: 174576498
• Report Number: 2134265-2019-14614
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0023231733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2019
• 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 Age: 70 YR
• Patient Weight: 65