MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK²¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493892809200

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that shaft break occurred.During preparation of a 2.00mm x 9mm maverick²¿ balloon catheter, upon wiring the balloon, it was noted that the balloon snapped off.The device was not used inside the patient and the procedure was completed with a emerge balloon catheter.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter in two pieces.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube shaft was completely separated 91.7cm from the hub.The fracture faces were oval as if kinked prior to separation.There are numerous hypotube and shaft kinks.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that shaft break occurred.During preparation of a 2.00mm x 9mm maverick²¿ balloon catheter, upon wiring the balloon, it was noted that the balloon snapped off.The device was not used inside the patient and the procedure was completed with a emerge balloon catheter.No patient complications were reported and the patient's status was good.

• Brand Name: MAVERICK²¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7566965
• MDR Text Key: 110007970
• Report Number: 2134265-2018-04872
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729369875
• UDI-Public: 08714729369875
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P860019
• 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: 05/09/2018

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: 02/02/2021
• Device Model Number: H7493892809200
• Device Catalogue Number: 38928-0920
• Device Lot Number: 21698215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 07/20/2018
• Supplement Dates FDA Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2018
• 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