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

Model Number H802228240022

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Same case as 2134265-2015-09021.It was reported that rotawire fracture occurred.A 330cm rotawire and a 1.50mm rotalink burr were selected to treat the target lesion located on the proximal right coronary artery (rca).During the procedure, a rotawire was crossed to the target vessel and the burr was advanced over the rotawire.Initial platform test was performed at 200,000 rpm outside the patient's body.After platforming, the burr was advanced into the patient's body and noticed that the wire was broken in two pieces.An extension was attached to the end of the wire where it had split and a microcatheter was advanced over the extended rotawire to the distal portion of the vessel to remove the broken wire.The physician advanced the same rotawire and retrieved the microcatheter.After the wire was retrieved, the same 1.5 burr was advanced over the wire but the burr would not go over the wire.The doctor ended up opening a new 1.5 burr and was able to get that over that new rotawire.Rotablation was performed in the proximal rca and followed by a balloon and the target lesion was stented.No further patient complications were reported and the patient's condition was fine.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.The unit returned has wire broken and kinked, as part of overall visual revision.The device has the guidewire detachment due to rotational wear in the middle of the device (199.5 cm from the proximal section).The distal tip was not returned.Overall length: couldn't be measured due to the device condition (wire broken in the middle of the device).Od of distal tip: couldn't be measured due to the device condition (distal tip was not returned).Od of middle of the device near to the broken section: 0.0091 inch within specification.Od of proximal section: 0.0091 inch within specification.No other issues noted during product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Same case as 2134265-2015-09021.It was reported that rotawire fracture occurred.A 330cm rotawire and a 1.50mm rotalink burr were selected to treat the target lesion located on the proximal right coronary artery (rca).During the procedure, a rotawire was crossed to the target vessel and the burr was advanced over the rotawire.Initial platform test was performed at 200,000 rpm outside the patient's body.After platforming, the burr was advanced into the patient's body and noticed that the wire was broken in two pieces.An extension was attached to the end of the wire where it had split and a microcatheter was advanced over the extended rotawire to the distal portion of the vessel to remove the broken wire.The physician advanced the same rotawire and retrieved the microcatheter.After the wire was retrieved, the same 1.5 burr was advanced over the wire but the burr would not go over the wire.The doctor ended up opening a new 1.5 burr and was able to get that over that new rotawire.Rotablation was performed in the proximal rca and followed by a balloon and the target lesion was stented.No further patient complications were reported and the patient's condition was fine.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5324482
• MDR Text Key: 34277021
• Report Number: 2134265-2015-09020
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• 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,Followup
• Report Date: 11/30/2015

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 Expiration Date: 06/23/2017
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 18130602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• 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: 65 YR