MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE APEX BALLOON CATHETER; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number UNK21

Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 02/13/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: the device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

Same case as mdr id 2134265-2017-02956 and 2134265-2017-02957.(b)(4) clinical study.It was reported that balloon rupture and vessel dissection occurred.In (b)(6) 2013, the patient underwent coronary angiography which revealed a 90% ostial and proximal stenosis in the third obtuse marginal (om) branch.Two days later, the patient underwent angioplasty to the third om using multiple balloons including 2.0 x 20 mm apex, 2.0 x 16mm apex nc, noncompliant balloon, and 2.5 x 20 mm apex balloons with multiple inflations at atmospheric pressures of up to 28 mmhg.However, two of the balloons ruptured and the proximal stenosis involving large third om was clearly non-dilatable; thus, it was not stented.The patient was scheduled for rotational atherectomy and provisional stenting.Following angioplasty of third om, there were multiple dissection planes noted; however, there was still fairly good flow into the distal disease-free segment of the vessel and the procedure was completed.No further complications were reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the 2.0 x 20 mm apex balloon catheter did not rupture, and only the 2.0 x 16mm apex nc and 2.5 x 20 mm apex balloon catheters ruptured which caused the multiple dissection planes.

• Brand Name: APEX BALLOON CATHETER
• 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: 6479616
• MDR Text Key: 72332395
• Report Number: 2134265-2017-02955
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Age: 36 YR