MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) ULTRASONIC IMAGING CATHETER - CORONARY; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number UNK97

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

Patient Problem Ventricular Fibrillation (2130)

Event Date 01/10/2014

Event Type  Injury  

Event Description

(b)(4) study.Same case as mdr id# 2134265-2014-00662 and 2134265-2014-00663.It was reported that ventricular fibrillation occurred.In (b)(6) 2014, the patient presented to the emergency room by ems with complaints of retrosternal chest pressure associated with nausea, vomiting and diaphoresis and was hospitalized on same day.Admission ecg revealed sinus rhythm with a junctional escape rhythm and ventricular rate of 47 beats per min there was inferior st elevation noted on ecg.The patient was noted to be hypotensive and bradycardic and required stabilization with administration of atropine and fluids.The subject responded to atropine with regards to improvement in av conduction with continuation of inferior myocardial infarction (mi) in evolution and possible old anteroseptal mi.The subject was diagnosed with mi and cardiac catheterization was recommended.Coronary angiography revealed, 100% occlusion in proximal vessel, acute marginal branch came off high in this area that also had clot that was jailed by implanted promus element stent interventional procedure.Choice pt wire and emerge 2.5 x15mm balloon were used however both were unable to advance in right posterior descending artery (r-pda).A 2.5x20mm emerge balloon was advanced across 100% narrowing in proximal right coronary artery (rca) and inflated multiple times to prepare the lesion.There was still clot burden noted which was treated with aspiration thrombectomy, which pulled out the thrombus, however there was still clot noted in r-pda.After balloon angioplasty of rca, the entire clotted area was treated with placement of 3.5 x 38 mm non-bsc stent, however there was significant burden of clot noted in r-pda, so 2.5x20 mm emerge balloon was advanced down to that area and used as dottering technique with multiple times to break the clot, which was successful at first but appeared to re-accumulate.Balloon was removed and lot of debris appeared with haziness in the mid vessel hence it was decided to perform ivus at this time.Boston scientific ivus was advanced across the lesion, which revealed good stent apposition with lot of debris in the mid portion of vessel; hence it was decided to cover this lesion with another stent.Ivus catheter was removed and 4.0x22mm non-bsc stent was placed where debris was noted.However, in r-pda there was no restoration of flow and clot had wedged distally.Subject was started on aggrastat therapy to see if this would help to dissolve the distal clot.During the ivus procedure, the subject developed ventricular fibrillation and was cardioverted back with 1 shock back to sinus rhythm.Four days post procedure, the event was considered resolved without residual effects and subject was discharged on aspirin.

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).

• Brand Name: ULTRASONIC IMAGING CATHETER - CORONARY
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3637658
• MDR Text Key: 3988784
• Report Number: 2134265-2014-00653
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK97
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR