MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number UNK525

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

Patient Problems Hematoma (1884); Pseudoaneurysm (2605)

Event Date 05/11/2016

Event Type  Injury  

Manufacturer Narrative

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

(b)(4) clinical study.It was reported that a hematoma with pseudoaneurysm occurred.In (b)(6) 2016, index procedure was performed.The target lesion was located in the right superficial femoral artery (sfa).A lotus introducer was placed and a v-18 control wire crossed the lesion.Subsequently, aortic valve was treated with balloon valvuloplasty and deployment of a 25 mm lotus valve.Successful repositioning of the lotus valve involved partial re-sheathing of the lotus valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus.Retrieval was not attempted.On the same day, a right thigh hematoma with right superficial femoral artery pseudoaneurysm was noted.Six days post procedure, the patient was hospitalized and thrombin injection was given as an intervention for sfa pseudoaneurysm.The event was considered not recovered and resolved.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the patient had bleeding and four days post index procedure, the patient was discharged with aspirin and warfarin.

Manufacturer Narrative

Describe event or problem, relevant tests/lab data and other relevant history updated.(b)(4).

Event Description

It was further reported that on (b)(6) 2016, the right thigh hematoma was due to the sfa branch injury by the guide wire.All the time of the event, the patient was on aspirin and warfarin.The patient's hemoglobin level and platelet count was noted to be trending down.The patient was transfused with 1 unit of packed red blood cells (prbc).Post procedure, course of the patient was complicated by hypotension and right forearm hematoma from injury to the radial artery.Four days later, the event was considered to be resolved with sequelae and the patient was discharged to skilled nursing facility on aspirin and clopidogrel on the same day.However, 2 days later, the patient was presented with right leg swelling and pain.Computed tomography arteriogram revealed pseudoaneurysm arising from a muscular branch of the right sfa.Subsequently, the event was treated with ultrasound guided thrombin injection into the pseudoaneurysm and was on medication and the patient was transfused with 1 unit of prbc on the following day.Four days after the transfusion, the event was considered to be resolved and the patient was discharged to rehabilitation/skilled nursing facility on aspirin and warfarin.

• Brand Name: V-18 CONTROL WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5722370
• MDR Text Key: 47284425
• Report Number: 2134265-2016-04996
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033742
• 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,Followup
• Report Date: 05/18/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/26/2016; 08/31/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 91 YR