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

Model Number H7493892812200

Device Problems Break (1069); Detachment Of Device Component (1104); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 07/22/2017

Event Type  malfunction  

Event Description

The procedure was a left leg angiogram.With the patient systemically heparinized, a 0.014 wire was advanced through the occlusion and then, a maverick balloon was advanced down into the calf, but could not reach all the way down to the ankle based upon shaft length.As this was the only short very low profile (2 mm balloon) possible, it appeared futile to do this.On advancing the catheter, and then pulling it back, the balloon broke off its catheter and needed to be retrieved from the left common femoral artery, by advancing another balloon over a buddy wire into the left common femoral artery, and then wedging it back into the sheath and retrieving it all successfully.

• Brand Name: MAVERICK²¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 6776907
• MDR Text Key: 82173491
• Report Number: 6776907
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: H7493892812200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR