MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) ROTAWIRE¿ AND WIRECLIP¿ TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number H802228240022

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

Patient Problem Rupture (2208)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

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: 2134265-2018-04547.It was reported that vessel rupture occurred.The target lesion was located in the calcified circumflex artery.The ostium of the circumflex was very tight.After a non-bsc guide wire and guide catheter were used, a 330cm rotawire¿ was advanced.Rotablation was commenced with a 1.50mm rotalink¿ plus at 175,000rpm for 6 cycles at a duration of 20 seconds each respectively.Subsequently, a non bsc guide catheter was then inserted and the rotawire¿ was removed; however, a rupture at the proximal circumflex was noted.A 2.50mm x 20mm emerge¿ balloon catheter was deployed, then a 3.00 x 28 synergy¿ drug-eluting stent was deployed, followed by 3.50 x 16 synergy¿ drug-eluting stent.Post-dilation was then performed with 4.00mm x 15mm nc emerge® balloon catheter.No further patient complications were reported.The patient was fine and recovering and will be brought back for repeat angiogram in 6 months.

• Brand Name: ROTAWIRE¿ AND WIRECLIP¿ TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7500253
• MDR Text Key: 107782018
• Report Number: 2134265-2018-04543
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• 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: 05/03/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2019
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 0021178808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2017
• 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