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

Model Number H7493892820200

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).   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 was completely separated 75cm from the hub. The fracture faces were oval as if kinked prior to separation. There are numerous hypotube and shaft kinks. 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 and the reported difficulty. 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 09-nov-2017. It was reported that crossing difficulties were encountered and shaft kink occurred. Vascular access was obtained via the femoral artery. The 85%, 28x3mm, concentric target lesion containing a lesion bend of between >45 and <90 degrees was located in the mild to moderate calcified right coronary artery (rca). A 2. 00mm x 20mm maverick²¿ balloon catheter was advanced but failed to cross the lesion. It was also noted that the shaft was kinked. 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 hypotube break.

• 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: 7043776
• Report Number: 2134265-2017-11574
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/29/2020
• Device Model Number: H7493892820200
• Device Catalogue Number: 38928-2020
• Device Lot Number: 20242561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial