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

Model Number UNK651

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 06/25/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

Event Description

It was reported that vessel dissection occurred. The target lesion was located in the proximal left anterior descending (lad) artery. A 3. 50 x 28 synergy ii drug-eluting stent was advanced but failed to cross the lesion. Pre-dilatation was then performed with a 2. 5x20 maverick and 3. 5x20 nc quantum apex balloon catheters, and the 3. 50 x 28 synergy ii drug-eluting stent was advanced again but still failed to cross the lesion. A guide wire was advanced and a 4. 0x20 nc quantum apex balloon catheter was used for further dilatation. However, during inflation, the plaque ruptured and the vessel was dissected. The procedure was terminated and the patient was sent to open heart surgery for a bypass graft. No further patient complications were reported.

• Brand Name: NC QUANTUM 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: 6707569
• Report Number: 2134265-2017-07068
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: UNK651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/26/2017
• 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 Age: 82 YR
• Patient Outcome(s): Required Intervention