MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number UNK509

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

Patient Problem ST Segment Depression (2487)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as 2134265-2016-10178.It was reported that the patient experienced st segment drop.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending (lad) artery.During percutaneous coronary intervention (pci), a 2.0mm x 15mm emerge¿ balloon catheter was inserted after advancing a non bsc guide wire to the target lesion.However, the balloon failed to cross the lesion.Subsequently, a non bsc extra back up (ebu) guide catheter was used for another attempt to reinsert the balloon; however, the device still failed to cross the lesion.Furthermore, the physician attempted to advance a non bsc balloon catheter to the target lesion; however the device also failed to cross.The physician opted to perform rotablation with a rotawire and a 1.75mm rotalink¿ plus; however, patient¿s st segment dropped and condition became unstable.Consequently, due to prolonged procedure time, the physician decided to reschedule for another procedure.No further patient complications were reported and the patient¿s condition is stable.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6110915
• MDR Text Key: 60280373
• Report Number: 2134265-2016-10350
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2016

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 Model Number: UNK509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/17/2016
• 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): Hospitalization
• Patient Age: 69 YR