MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK¿ BURR; CATHETER, CORONARY, ATHERECTOMY

Model Number H802227680040

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

Patient Problems Intimal Dissection (1333); Perforation of Vessels (2135); Pericardial Effusion (3271)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.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

It was reported that the burr dissected the vessel and the patient experienced vessel perforation and pericardial effusion.The target lesion was located in the mildly tortuous and moderate to severely calcified mid left anterior descending artery (lad).A 1.75mm rotalink¿ burr was selected for use.During the procedure, it was noted that the proximal lesion in the lad was treated successfully after the third ablation.Furthermore, ablation in the mid lesion in the second diagonal branch was performed and it was treated successfully after the fourth ablation.During removal of the burr, it was noticed after taking a picture that there was a 5mm dissection in the distal lad and a vessel perforation was also observed distal to the dissection.A non-bsc balloon catheter was then inflated proximal to the mid lesion and proximal to the dissection.When the balloon was deflated, rewiring was done utilizing a non-bsc guidewire.The balloon was inflated again to dilate the vessel, thus closing the dissected portion.A synergy¿ stent was then positioned across the dissection and perforation.Blood flow from the lad into the pericardium was consequently blocked and a pericardial effusion drain was inserted to the patient.This was removed early the next morning and had drained only a very small amount of fluid from the pericardium.No further patient complications were reported and the patient's status was stable.

• Brand Name: ROTALINK¿ BURR
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7139088
• MDR Text Key: 95526848
• Report Number: 2134265-2017-12983
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185840
• UDI-Public: 08714729185840
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: H802227680040
• Device Catalogue Number: 22768-004
• Device Lot Number: 0020947590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• 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