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

Model Number H749236310030

Device Problem Device Damaged by Another Device (2915)

Patient Problem Perforation of Vessels (2135)

Event Date 11/30/2016

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.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 mdr id: 2134265-2016-11819.It was reported that the rotawire was fractured and perforated the vascular wall.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery (rca).A 1.50mm rotalink¿ plus and a rotawire¿ were selected for use.During procedure after the rotawire was inserted in the target lesion, test rotation was performed at 200,000 rpm outside the patient¿s body.After which, the burr was advanced and ablation was performed in the rca.The burr was then advanced to the area right before reaching the shoulder of the target lesion.During ablation of the shoulder part, it was noticed that the rotawire was bent and detached.An attempt to retrieve the wire was made; however it was noticed that the tip of the wire perforated the vascular wall.Removing the wire was difficult and had to be surgically recovered.No further patient complications were reported.

• Brand Name: ROTALINK¿ PLUS
• 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: 6190327
• MDR Text Key: 62854952
• Report Number: 2134265-2016-11820
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: (01)08714729228363(17)20180531(10)0019432035.
• Combination Product (y/n): N
• 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: 11/30/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0019432035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2016
• 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