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

Model Number H749236310050

Device Problem Entrapment of Device (1212)

Patient Problem Vasoconstriction (2126)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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: 2134265-2017-07719.It was reported that the rotawire was stuck in the lesion and with the rotaburr and the patient experienced vasospasm.The 90% stenosed target lesion was located in a mildly tortuous and severely calcified proximal to middle left anterior descending artery (lad).A 330cm rotawire¿ and 2.0mm rotalink¿ plus were selected for use.Ablation was performed three times with the rotaburr; however while on dynaglide to withdraw the rotawire, the distal end of this device was stuck on peripheral blood because of spasm.It was further observed under fluoroscopy that the tip of the rotawire was stretched.Also, resistance was encountered between the burr and wire.The devices had to be removed together as a whole.A coronary dilating agent was administered and a micro catheter was inserted to successfully remove the burr and wire.The rotawire was checked outside the patient's body and about 2mm of the coil from the tip was stretched at about 10cm.The procedure was completed with this device.There were no further patient complications reported.

• Brand Name: ROTALINK¿ PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6787612
• MDR Text Key: 82460918
• Report Number: 2134265-2017-08486
• Device Sequence Number: 1
• Product Code: MCX
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2017

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 Model Number: H749236310050
• Device Catalogue Number: 23631-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/11/2017
• 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): Required Intervention