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

Model Number H7493892820200

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The tip is damaged.The hypotube is kinked 68.5cm from the hub.The balloon has a 21mm longitudinal tear starting at the proximal balloon waist.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage.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

Reportable based on device analysis completed on 28-may-2018.It was reported that shaft kink occurred.The 90% stenosed, 20x2.0mm target lesion was located in the moderately tortuous and calcified left anterior descending artery.A 2.00mm x 20mm maverick²¿ balloon catheter was advanced for dilatation.However, it was noted that the shaft was kinked 25cm away from the physician's hand.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed balloon longitudinal tear.

• 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: 7615957
• MDR Text Key: 111559677
• Report Number: 2134265-2018-05325
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00871472937016
• UDI-Public: 0871472937016
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P860019
• 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
• Report Date: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2020
• Device Model Number: H7493892820200
• Device Catalogue Number: 38928-2020
• Device Lot Number: 0020970654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• 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: 66 YR
• Patient Weight: 58