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

Model Number UNK731

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

Patient Problem Intimal Dissection (1333)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.If there is any further relevant information, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-04247.It was reported that vessel dissection occurred.The target lesion was located in the calcified left anterior descending (lad) artery.An opticross¿ 6 imaging catheter was advanced for visualization but failed to cross.The device was removed and flushing was done to advanced the opticross again but then the physician could not get the telescope portion to come back to its original position, so another opticross imaging catheter was used instead.Subsequently, a 2.25mm x 16mm synergy ii stent was advanced to treat the lesion.However, the device became stuck on either the recently deployed non-bsc stent or in the calcified lesion and the stent came off from the balloon inside the patient's body.The physician managed to crush the dislodged stent with a larger 3.5mm x 20mm non-bsc stent in the lad to prevent embolization.After that, post-dilatation was done with 1.5mm x 15mm emerge balloon catheter; moreover, a vessel dissection was noted after ballooning.The patient was then sent for bypass to treat the dissection.No further patient complications were noted.

• Brand Name: EMERGE
• 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: 6533622
• MDR Text Key: 74048725
• Report Number: 2134265-2017-04569
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113220
• 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: 04/12/2017

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: UNK731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 05/01/2017
• 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
• Treatment: 2.25MM X 16MM SYNERGY II STENT
• Patient Outcome(s): Required Intervention