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

Model Number H749RB4300100

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2017

Event Type  malfunction  

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 a catheter shaft fracture occurred.The 80% stenosed, 15 x 3 mm target lesion was located in the mildly tortuous and severely calcified left anterior descending (lad) artery.A 10/3.00 flextome" cutting balloon" was selected for use.During procedure, it was noted that the delivery shaft became fractured 80 cm from the hub.Furthermore, it was noted that the catheter was not completely fractured.The device was completely removed from the patient's body.The physician was able to directly remove the device and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned in two separate pieces consisting of the manifold with 570mm of hypotube and the balloon with the polymer extrusion, midshaft and 530mm of hypotube.A visual and tactile examination of the hypotube observed a complete break.The balloon folds were observed to be relaxed which may have occurred when the balloon protector was removed.There was no evidence that the balloon had been subjected to positive pressure.A visual and microscopic examination identified no damage to the tip, markerbands or blades of the device.All blades were present and fully bonded to the balloon material.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that a catheter shaft fracture occurred.The 80% stenosed, 15x3mm target lesion was located in the mildly tortuous and severely calcified left anterior descending (lad) artery.A 10/3.00 flextome" cutting balloon" was selected for use.During procedure, it was noted that the delivery shaft became fractured 80cm from the hub.Furthermore, it was noted that the catheter was not completely fractured.The device was completely removed from the patient's body.The physician was able to directly remove the device and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7087827
• MDR Text Key: 94949830
• Report Number: 2134265-2017-11998
• 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: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2019
• Device Model Number: H749RB4300100
• Device Catalogue Number: RB430010
• Device Lot Number: 20017960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2016
• 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 Age: 80 YR
• Patient Weight: 60