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

Model Number UNK351

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id# 2134265-2018-06286 (b)(6) study.It was reported that balloon positioning/placement issue occurred.In (b)(6) 2013, the patient presented due to unstable angina and cardiac catheterization was recommended.The target lesion was a de novo lesion located in the proximal right coronary artery (rca) with 99% stenosis and was 5mm long with a reference vessel diameter of 4mm.Following pre-dilatation with a 3.00mm balloon, a 3.0x16mm promus element plus stent was introduced but could not be advanced beyond the ostium of the rca.The same balloon was used again and inflated several times up to 14atm.A 4.00x16mm promus element¿ plus drug-eluting stent (des) was implanted and following post dilatation, the residual stenosis was 0% with timi 3 flow noted.On the following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient presented to hospital for a follow up care visit.The patient reported complaints of significant dyspnea on exertion which was worse than last visit, associated with tiredness and shortness of breath.The patient was diagnosed with unstable angina and was hospitalized the same day.Coronary angiography revealed 80% in-stent restenosis located in the proximal rca.During treatment of isr of the study stent, initially a 4.5 x 15 mm quantum maverick balloon catheter was used which inflated to high pressure.This resulted in watermelon seeding of the balloon.Follow-up angiography demonstrated persistent 40% residual stenosis.A 5mm quantum maverick balloon catheter was inflated to 20 atmospheres with 30% residual stenosis and the procedure was completed with no other complications.The following day, the event was considered as resolved and the patient was discharged from the hospital on the same day.

• Brand Name: QUANTUM MAVERICK 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: 7675663
• MDR Text Key: 113618423
• Report Number: 2134265-2018-06373
• 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
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/10/2018
• 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): Required Intervention
• Patient Age: 71 YR