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

Model Number H749236310030

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

Patient Problems Cardiac Arrest (1762); Death (1802); Pulmonary Edema (2020); Tachycardia (2095)

Event Date 09/17/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).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 2134265-2015-06977 and 2134265-2015-06978.It was reported that the patient died.Vascular access was obtained via the femoral artery.The 90% stenosed, 35x3.2mm, concentric, de novo target lesion was located in the mildly tortuous and mild to moderately calcified ostial to proximal left anterior descending (lad) artery.A 1.50mm rotalink plus and 330cm rotawire were used for treatment.The speed was set at 160,000rpms and ablations were done three times at 40 seconds duration.There were no restrictions encountered and the wire had no fracture or bending issues.Post-dilatation was then performed using a 2.75 nc balloon catheter.However, immediately after post-dilatation, the patient experienced tachycardia resulting in pulmonary edema.A 3.00x38mm promus element long drug-eluting stent was then advanced and implanted.The patient was also treated with intra-aortic balloon pump (iabp) and cardiac massaging; however, patient's condition did not improve.Subsequently, the patient went into cardiac arrest and died.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5152742
• MDR Text Key: 28364484
• Report Number: 2134265-2015-06976
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 09/22/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0016997782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2014
• 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): Death
• Patient Age: 58 YR