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

Model Number H802227680030

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as 2134265-2015-09020.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 lot number update from unknown to 18303396.Device expiration date update from unknown to 07/31/2017.Device manufactured date update from unknown to 08/25/2015.(b)(4).Device evaluated by mfr: the device was returned for evaluation.A visual examination of the complaint unit was carried out.The handshake connection was inspected and a tug test was performed and no damage was noted.The burr was microscopically examined and revealed that the annulus was damaged/blocked.No issues were noted with the exposed brass on the plated back half of the burr.No other issues or defects were observed during product analysis of the returned device.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 2134265-2015-09020.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: 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5324481
• MDR Text Key: 34277702
• Report Number: 2134265-2015-09021
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: H802227680030
• Device Catalogue Number: 22768-003
• Device Lot Number: 18303396
• 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: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2015
• 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 Age: 65 YR